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선택지 정리됨

Biliary tract cancer / cholangiocarcinoma: 국가별 선택지

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선택지 정리됨고형암최종 확인 2026.06

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임상시험 검색어

Biliary tract cancer / cholangiocarcinoma clinical trial

국가별 선택지

국가별 치료 선택지

공식 규제·평가 기관 출처를 바탕으로 한 국가별 승인·접근 상태입니다. 무엇이 어디에 존재하는지를 보여줄 뿐, 추천이 아닙니다.

United States

  • durvalumab (Imfinzi) plus gemcitabine and cisplatin[1]FDA-approvedno biomarker restriction stated by FDA approval notice; FDA approval notice describes TOPAZ-1 enrolling patients with histologically confirmed locally advanced unresectable or metastatic biliary tract cancer who had not previously received systemic therapy for advanced disease. · The approval notice does not replace the current prescribing information, payer coverage, or patient-specific eligibility review. Confidence/conflicts: high for FDA approval notice; no conflict identified.
  • futibatinib (Lytgobi)[2]FDA accelerated approvalFGFR2 gene fusion or other rearrangement; previously treated unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma. · The FDA approval notice specifies accelerated approval and an intrahepatic cholangiocarcinoma population. This does not imply use for all biliary tract cancers or for patients without the biomarker. Confidence/conflicts: high for FDA approval notice; no conflict identified.
  • ivosidenib (Tibsovo)[3]FDA-approvedIDH1 mutation detected by an FDA-approved test; previously treated locally advanced or metastatic cholangiocarcinoma; trial population had progression after at least one and not more than two prior regimens including at least one gemcitabine- or fluorouracil-containing regimen. · This is a biomarker-selected option; source language does not imply use without IDH1 mutation or outside the stated prior-treatment context. Confidence/conflicts: high for FDA approval notice; no conflict identified.
  • palliative therapy including biliary drainage approaches such as stenting; radiation therapy may be part of palliation in selected contexts[4]Standard option (per NCI PDQ)unresectable, metastatic, or recurrent bile duct cancer. · This supportive-care cell describes options to discuss for symptoms or biliary obstruction and does not establish suitability for any specific procedure. Confidence/conflicts: high for NCI PDQ palliative/supportive treatment overview; no conflict identified.
  • pembrolizumab (Keytruda) plus gemcitabine and cisplatin[5]FDA-approvedno biomarker restriction stated by FDA approval notice; FDA describes KEYNOTE-966 enrolling patients with locally advanced unresectable or metastatic biliary tract cancer who had not received prior systemic therapy for advanced disease. · The FDA approval notice should be paired with current prescribing information and clinical review; it does not establish eligibility or preference over other approved regimens. Confidence/conflicts: high for FDA approval notice; no conflict identified.
  • pemigatinib (Pemazyre)[6]FDA accelerated approvalFGFR2 fusion or other rearrangement detected by an FDA-approved test; previously treated unresectable locally advanced or metastatic cholangiocarcinoma. · The FDA review states accelerated approval was based on overall response rate and duration of response, with continued approval potentially contingent on confirmatory evidence. Current label status should be checked before patient-facing reuse. Confidence/conflicts: medium-high; FDA review supports the approval basis and indication, but current prescribing information should be refreshed before patient-facing reuse. No conflict identified.
  • surgical resection, including extended resection for selected perihilar/Klatskin tumors[4]Standard option (per NCI PDQ)resectable localized bile duct cancer. · NCI emphasizes that treatment depends primarily on whether the cancer can be completely removed by surgery. This is not a statement that any individual tumor is resectable. Confidence/conflicts: high for NCI PDQ treatment-option overview; no conflict identified.

European Union

  • durvalumab (Imfinzi) plus gemcitabine and cisplatin[7]EMA authorisedno biomarker restriction stated in EMA product information; first-line unresectable or metastatic biliary tract cancer. · EMA central authorisation does not determine national reimbursement, sequencing, or access in every EU member state, including Germany and France. Confidence/conflicts: high for EMA-authorised indication; national reimbursement not inferred. No conflict identified.
  • durvalumab (Imfinzi) plus gemcitabine and cisplatin[8]G-BA benefit assessmentno biomarker restriction stated by G-BA assessment; first-line unresectable or metastatic biliary tract cancer. · This is a G-BA courtesy translation; only the German version is legally binding. Additional-benefit language is not an individual access or eligibility decision. Confidence/conflicts: high for G-BA courtesy-translation content; German original legally binding. No conflict identified.
  • durvalumab (Imfinzi) plus gemcitabine and cisplatin[9]HAS reimbursement opinionno biomarker restriction stated by HAS opinion; first-line unresectable or metastatic biliary tract cancer. · HAS opinion is a French reimbursement/clinical-benefit context and does not establish individual eligibility, center formulary details, or sequencing. Confidence/conflicts: high for HAS reimbursement opinion; no conflict identified.
  • futibatinib (Lytgobi)[10]EMA authorisedFGFR2 abnormality / FGFR2 fusion or rearrangement; progressed after previous treatment with at least one cancer medicine. · Conditional authorisation means additional evidence is expected. EMA central authorisation does not establish reimbursement or availability in every EU member state. Confidence/conflicts: high for EMA-authorised indication; no conflict identified.
  • ivosidenib (Tibsovo)[11]EMA authorisedIDH1 R132 mutation; previously treated by at least one prior systemic line. · EMA notes Tibsovo is under additional monitoring. National reimbursement and access are not established by the central EPAR alone. Confidence/conflicts: high for EMA-authorised indication; no conflict identified.
  • pembrolizumab (Keytruda) plus gemcitabine and cisplatin[12]EMA authorisedno biomarker restriction stated in EMA indication; first-line locally advanced unresectable or metastatic biliary tract carcinoma. · EMA authorisation is central regulatory status; national reimbursement and formulary access require country-level verification. Confidence/conflicts: high for EMA-authorised indication; no conflict identified.
  • pembrolizumab (Keytruda) plus gemcitabine and cisplatin[13]HAS reimbursement opinionno biomarker restriction stated by HAS opinion; first-line locally advanced unresectable or metastatic biliary tract carcinoma. · HAS opinion is reimbursement/clinical-benefit evidence; it does not determine individual eligibility, treatment preference, or local hospital formulary status. Confidence/conflicts: high for HAS reimbursement opinion; no conflict identified.
  • pemigatinib (Pemazyre)[14]EMA authorisedFGFR2 fusion or rearrangement; after at least one prior line of systemic therapy. · Conditional marketing authorisation means EMA expects further evidence; national reimbursement and local molecular-testing pathways vary by member state. Confidence/conflicts: high for EMA-authorised indication; no conflict identified.
  • pemigatinib (Pemazyre)[15]G-BA benefit assessmentFGFR2 fusion or rearrangement; after at least one prior line of systemic therapy. · This is a G-BA courtesy translation; only the German version is legally binding. G-BA states the medicine was approved under special conditions, with further evidence anticipated. Confidence/conflicts: high for G-BA courtesy-translation content; German original legally binding. No conflict identified.
  • pemigatinib (Pemazyre)[16]HAS reimbursement opinionFGFR2 fusion or rearrangement; from second line of treatment; after at least one prior systemic line in the marketing-authorisation subgroup; not eligible for FOLFOX per HAS care-pathway language. · HAS narrows the role relative to the broader marketing authorisation and explicitly notes limited non-comparative evidence and adverse-event concerns. Confidence/conflicts: high for HAS care-pathway/reimbursement opinion; no conflict identified.

United Kingdom

Japan

  • durvalumab (Imfinzi) plus gemcitabine and cisplatin[21]Approvedno biomarker restriction stated in fetched approval announcement; curatively unresectable biliary tract cancer; TOPAZ-1 approval context. · This is a manufacturer approval announcement citing Japan authorisation; PMDA/MHLW current label and reimbursement details remain a follow-up gap. Confidence/conflicts: medium-high; source supports Japan authorisation but is manufacturer-authored, not PMDA label. No conflict identified.
  • futibatinib (Lytgobi)[22]PMDA-approved (Japan)FGFR2 gene fusion-positive; PMDA review discusses FGFR2 gene fusion/rearrangement evidence; progressed after cancer chemotherapy; first-line and postoperative adjuvant efficacy/safety not established per PMDA review. · PMDA notes limits in evidence, including no established first-line or postoperative adjuvant use and uncertainty around some rearrangement categories. Confirm current Japanese label and testing requirements. Confidence/conflicts: high for PMDA-reviewed indication; no conflict identified. Manufacturer announcement aligns with PMDA review. Availability/reimbursement outside the approving regulator not established.
  • pembrolizumab (Keytruda) with chemotherapy[23]PMDA-approved (Japan)no biomarker restriction stated in fetched PMDA regulatory-update abstract/page title; biliary tract cancer approval; detailed line/combination wording should be confirmed against the Japanese PMDA list or label. · The fetched article confirms the PMDA approval update but does not provide full English label wording in the accessible page; Japanese primary source/label review remains needed before patient-facing reuse. Confidence/conflicts: medium; approval is supported, but exact Japanese indication wording requires primary-label confirmation. No conflict identified. Availability/reimbursement outside the approving regulator not established.

Korea

  • durvalumab (Imfinzi) plus gemcitabine and cisplatin[24]Approvedno biomarker restriction stated in fetched reimbursement article; first-line unresectable locally advanced or metastatic biliary tract cancer. · This is a market-access news source summarizing Korean national health insurance coverage, not an MFDS label or HIRA primary notice. Confirm current HIRA/MFDS criteria and co-pay details locally. Confidence/conflicts: medium; reimbursement claim is source-backed but needs HIRA/MFDS primary confirmation. No conflict identified.

China

  • durvalumab (Imfinzi) plus gemcitabine and cisplatin[25]Approvedno biomarker restriction stated in fetched approval announcement; first-line locally advanced or metastatic biliary tract cancer. · This is a manufacturer announcement citing NMPA approval, not a fetched NMPA primary label. National reimbursement, hospital access, and current label wording require follow-up. Confidence/conflicts: medium-high; source supports NMPA-attributed approval but primary regulator label remains needed. No conflict identified.

Russia

  • Durvalumab (Imfinzi) plus gemcitabine and cisplatin[26]ApprovedNot biomarker-selected; First-line treatment for advanced unresectable or metastatic biliary tract cancer. · Direct GRLS/official label was not fetched in this batch; approval is based on oncology.ru reporting that cites the Russian Imfinzi medical-use instruction. Reimbursement/procurement and center availability remain separate. Confidence/conflicts: Medium-high; current guideline and Russia approval reports align, but direct GRLS label remains source-pending. Earlier 2022 Vidal page stated the indication was not yet registered before later Russia approval reporting. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Durvalumab (Imfinzi) plus gemcitabine and cisplatin[26]ApprovedNot biomarker-selected; First-line treatment for advanced unresectable or metastatic biliary tract cancer. · Direct GRLS/official label was not fetched in this batch; approval is based on oncology.ru reporting that cites the Russian Imfinzi medical-use instruction. Reimbursement/procurement and center availability remain separate. Confidence/conflicts: Medium-high; current guideline and Russia approval reports align, but direct GRLS label remains source-pending. Earlier 2022 Vidal page stated the indication was not yet registered before later Russia approval reporting. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Molecularly directed therapy selected by validated tumor testing; source specifically discusses FGFR inhibitor class evidence including erdafitinib in FGFR-altered tumors[26]Standard option (per MedElement clinical recommendations portal)HER2/ERBB2 alteration, BRAF V600E, MSI-H/dMMR, TMB-high, FGFR2 translocation/fusion, ALK, NTRK, RET alterations as targetable molecular-alteration classes in source; Refractory advanced unresectable biliary tract cancer after standard chemotherapy context. · This is a molecular-testing and targeted-therapy class recommendation, not proof that each named targeted drug is approved or reimbursed for BTC in Russia. Direct Russian labels and access pathways remain source-pending. Confidence/conflicts: Medium for class-level guideline recommendation; product-specific approval and reimbursement are not established. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Pembrolizumab plus gemcitabine and cisplatin[26]Standard option (per MedElement clinical recommendations portal)Not biomarker-selected; First-line treatment option for advanced unresectable or metastatic biliary tract cancer. · This finding records a guideline-recommended option only; Russian regulatory approval, reimbursement, and local access for pembrolizumab in this BTC indication were not confirmed by a direct regulator source this cycle. Confidence/conflicts: Medium-high for guideline-recommended role; regulator/reimbursement status source-pending. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Pembrolizumab plus gemcitabine and cisplatin[26]Standard option (per MedElement clinical recommendations portal)Not biomarker-selected; First-line treatment option for advanced unresectable or metastatic biliary tract cancer. · This finding records a guideline-recommended option only; Russian regulatory approval, reimbursement, and local access for pembrolizumab in this BTC indication were not confirmed by a direct regulator source this cycle. Confidence/conflicts: Medium-high for guideline-recommended role; regulator/reimbursement status source-pending. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Radical surgical treatment, including bile duct resection/hepatectomy, pancreaticoduodenal resection for distal bile duct cancer, extended cholecystectomy for selected gallbladder cancer, and preoperative biliary decompression when indicated[26]Standard option (per MedElement clinical recommendations portal)Not biomarker-selected; Resectable disease and preoperative preparation; obstruction/cholangitis contexts for biliary drainage. · Surgical and drainage decisions depend on anatomic site, resectability, liver remnant, metastatic exclusion, institutional equipment, and specialist experience. Russian-language clinical content requires human review. Confidence/conflicts: Medium-high for guideline content; local center capability and current Ministry-hosted text remain follow-up gaps. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Radical surgical treatment, including bile duct resection/hepatectomy, pancreaticoduodenal resection for distal bile duct cancer, extended cholecystectomy for selected gallbladder cancer, and preoperative biliary decompression when indicated[26]Standard option (per MedElement clinical recommendations portal)Not biomarker-selected; Resectable disease and preoperative preparation; obstruction/cholangitis contexts for biliary drainage. · Surgical and drainage decisions depend on anatomic site, resectability, liver remnant, metastatic exclusion, institutional equipment, and specialist experience. Russian-language clinical content requires human review. Confidence/conflicts: Medium-high for guideline content; local center capability and current Ministry-hosted text remain follow-up gaps. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Second-line chemotherapy options including FOLFOX- or FOLFIRI-type fluoropyrimidine/platinum/irinotecan regimens[26]Standard option (per MedElement clinical recommendations portal)Not biomarker-selected; Second-line treatment after prior systemic therapy for disseminated biliary tract cancer. · Regimen selection depends on prior therapy, tolerance, performance status, organ function, and symptom-control goals. This entry does not establish reimbursement or brand availability. Confidence/conflicts: Medium-high for guideline role; individual access and regimen details not inferred. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.

Thailand

  • Chemotherapy regimens including gemcitabine/cisplatin and fluoropyrimidine- or platinum-based regimens as referenced in Thai NCI guideline material[27]Standard option (per Thailand National Cancer Institute)Not biomarker-selected; Advanced biliary tract cancer / advanced cholangiocarcinoma chemotherapy context. · This Thai NCI guideline PDF is legacy material and predates modern immunotherapy and targeted-therapy approvals; use only as historical/local pathway context until a current Thai guideline is fetched. Thai text requires human review. Confidence/conflicts: Medium; source is local/national but legacy and should be superseded by newer Thai institutional guidance if located. Primary source is in Thai. English summary pending human review — confirm exact wording with your care team.
  • Durvalumab (Imfinzi) in combination with gemcitabine and cisplatin[28]ApprovedNot biomarker-selected in source; Locally advanced or metastatic BTC; the Thai NDI document provides the indication but does not state a local line-of-therapy sequence beyond the indication wording. · NDI prescribing document supports indication text, not reimbursement, center formulary status, or individual eligibility. The document references source prescribing-information versions; local Thai regulatory status should be cross-checked in the Thai FDA product record when available. Confidence/conflicts: High for Thai NDI prescribing-document indication; reimbursement and product-record details not established.
  • Durvalumab (Imfinzi) in combination with gemcitabine and cisplatin[28]ApprovedNot biomarker-selected in source; Locally advanced or metastatic BTC; the Thai NDI document provides the indication but does not state a local line-of-therapy sequence beyond the indication wording. · NDI prescribing document supports indication text, not reimbursement, center formulary status, or individual eligibility. The document references source prescribing-information versions; local Thai regulatory status should be cross-checked in the Thai FDA product record when available. Confidence/conflicts: High for Thai NDI prescribing-document indication; reimbursement and product-record details not established.
  • Pembrolizumab (Keytruda) in combination with gemcitabine and cisplatin[29]ApprovedNot biomarker-selected in source; Locally advanced unresectable or metastatic BTC; line number not separately stated in the fetched indication excerpt. · NDI prescribing document supports indication text but does not establish reimbursement, sequencing versus durvalumab-based therapy, or availability at a particular Thai hospital. Confidence/conflicts: High for Thai NDI prescribing-document indication; reimbursement and sequencing not established.
  • Pembrolizumab (Keytruda) in combination with gemcitabine and cisplatin[29]ApprovedNot biomarker-selected in source; Locally advanced unresectable or metastatic BTC; line number not separately stated in the fetched indication excerpt. · NDI prescribing document supports indication text but does not establish reimbursement, sequencing versus durvalumab-based therapy, or availability at a particular Thai hospital. Confidence/conflicts: High for Thai NDI prescribing-document indication; reimbursement and sequencing not established.
  • Radiotherapy/chemoradiotherapy in selected research or palliative contexts; percutaneous transhepatic biliary drainage (PTBD) for drainage or palliation[27]Standard option (per Thailand National Cancer Institute)Not biomarker-selected; Palliative symptom-control, biliary drainage, and selected study/locoregional contexts. · This is legacy Thai guideline material with Thai text that needs human review; it should not be treated as current definitive Thai radiotherapy guidance. PTBD/radiation suitability depends on anatomy, infection, coagulation status, ascites, and local expertise. Confidence/conflicts: Medium for local supportive/radiation context; current practice may differ and newer sources are needed. Primary source is in Thai. English summary pending human review — confirm exact wording with your care team.
  • Radiotherapy/chemoradiotherapy in selected research or palliative contexts; percutaneous transhepatic biliary drainage (PTBD) for drainage or palliation[27]Standard option (per Thailand National Cancer Institute)Not biomarker-selected; Palliative symptom-control, biliary drainage, and selected study/locoregional contexts. · This is legacy Thai guideline material with Thai text that needs human review; it should not be treated as current definitive Thai radiotherapy guidance. PTBD/radiation suitability depends on anatomy, infection, coagulation status, ascites, and local expertise. Confidence/conflicts: Medium for local supportive/radiation context; current practice may differ and newer sources are needed. Primary source is in Thai. English summary pending human review — confirm exact wording with your care team.

출처

  1. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  2. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  3. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  4. National Cancer Institute (NCI) — national cancer agency evidence summary · national cancer agency evidence summary
  5. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  6. U.S. Food and Drug Administration (FDA) — multidisciplinary FDA review / approval package · multidisciplinary FDA review / approval package
  7. European Medicines Agency (EMA) — regulator product information / EPAR · regulator product information / EPAR
  8. Gemeinsamer Bundesausschuss (G-BA) — national benefit assessment justification / courtesy translation · national benefit assessment justification / courtesy translation
  9. Haute Autorité de Santé (HAS) — national HTA/reimbursement opinion · national HTA/reimbursement opinion
  10. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  11. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  12. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  13. Haute Autorité de Santé (HAS) — national HTA/reimbursement opinion · national HTA/reimbursement opinion
  14. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  15. Gemeinsamer Bundesausschuss (G-BA) — national benefit assessment resolution / courtesy translation · national benefit assessment resolution / courtesy translation
  16. Haute Autorité de Santé (HAS) — national HTA/reimbursement opinion · national HTA/reimbursement opinion
  17. NHS — national health service patient information · national health service patient information
  18. National Institute for Health and Care Excellence (NICE) — national HTA/guideline recommendation · national HTA/guideline recommendation
  19. National Institute for Health and Care Excellence (NICE) — national HTA/guideline recommendation · national HTA/guideline recommendation
  20. National Institute for Health and Care Excellence (NICE) — national guideline · national guideline
  21. AstraZeneca — manufacturer approval announcement citing Japan authorisation · manufacturer approval announcement citing Japan authorisation
  22. Taiho Pharmaceutical — manufacturer approval announcement citing MHLW approval · manufacturer approval announcement citing MHLW approval
  23. International Journal of Clinical Oncology / PMDA Regulatory Update — peer-reviewed regulatory update citing PMDA approved-drugs list · peer-reviewed regulatory update citing PMDA approved-drugs list
  24. MAESTrO Database — market-access news report · market-access news report
  25. AstraZeneca — manufacturer approval announcement citing NMPA · manufacturer approval announcement citing NMPA
  26. MedElement clinical recommendations portal — Russian clinical guideline mirror / systemic therapy recommendations · Russian clinical guideline mirror / systemic therapy recommendations
  27. Thailand National Cancer Institute — national cancer guideline PDF / legacy clinical practice guideline · national cancer guideline PDF / legacy clinical practice guideline
  28. Thai National Drug Information / Thai FDA-MOPH — prescribing information PDF / regulator drug-information repository · prescribing information PDF / regulator drug-information repository
  29. Thai National Drug Information / Thai FDA-MOPH — prescribing information PDF / regulator drug-information repository · prescribing information PDF / regulator drug-information repository

위 내용은 공식 규제·접근 상태일 뿐, 의학적 조언이나 추천이 아니고, 적격성을 판단하지도 않습니다. 어떤 선택지가 적합한지는 환자의 상황과 종양내과 팀에 달려 있습니다. 규제 상태는 바뀔 수 있으니 표시된 출처에서 확인하세요. 임상 세부 내용은 영문이 정본입니다. 최종 확인 2026-06-12.