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Pancreatic cancer: 국가별 선택지

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선택지 정리됨고형암최종 확인 2026.06

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임상시험 검색어

Pancreatic cancer 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

  • chemotherapy with possible chemoradiation or radiation therapy approaches as described by NCI PDQ[1]Standard option (per NCI PDQ)not biomarker-specific; locally advanced pancreatic cancer; selected non-metastatic disease after chemotherapy. · NCI PDQ describes radiation/chemoradiation options by disease setting, not a universal sequence. Local anatomy, systemic disease status, symptoms, and center expertise matter. Confidence/conflicts: high for NCI PDQ treatment-category support; no conflict identified.
  • irinotecan liposome (Onivyde) with fluorouracil and leucovorin[2]FDA-approvednot biomarker-specific; after disease progression following gemcitabine-based therapy. · This is an FDA-label indication after gemcitabine-based therapy. It does not imply eligibility, benefit, or tolerability for an individual patient. Confidence/conflicts: high for FDA-label indication; no conflict identified.
  • irinotecan liposome (Onivyde) with oxaliplatin, fluorouracil, and leucovorin[2]FDA-approvednot biomarker-specific; first-line metastatic pancreatic adenocarcinoma in adults. · This is an FDA-label indication; individual suitability, contraindications, organ function, and supportive-care needs require clinician review. No dosing is provided here. Confidence/conflicts: high for FDA-label indication; no conflict identified.
  • olaparib (Lynparza)[3]FDA-approveddeleterious or suspected deleterious germline BRCA-mutated; maintenance after at least 16 weeks of first-line platinum-based chemotherapy without progression. · The label requires germline BRCA mutation status and non-progression after first-line platinum-based chemotherapy. It does not establish suitability for people without that biomarker/setting. Confidence/conflicts: high for FDA-label indication; no conflict identified.
  • surgery for resectable or borderline resectable pancreatic cancer, including pancreaticoduodenectomy or distal/subtotal pancreatectomy approaches as appropriate to tumor location[1]Standard option (per NCI PDQ)not biomarker-specific; resectable or borderline resectable pancreatic cancer. · Surgical candidacy depends on staging, anatomy, performance status, and multidisciplinary assessment. This entry is an option to discuss with the treating team, not a statement that surgery is available or appropriate for an individual patient. Confidence/conflicts: high for NCI PDQ treatment-category support; no conflict identified.
  • zenocutuzumab-zbco (Bizengri)[4]FDA accelerated approvalNRG1 gene fusion; after disease progression on or after prior systemic therapy. · Approval is accelerated and limited to NRG1 fusion-positive disease in the specified setting. Continued approval may depend on confirmatory evidence, and biomarker testing is essential. Confidence/conflicts: high for FDA approval notice; no conflict identified.

European Union

  • irinotecan hydrochloride trihydrate pegylated liposomal (Onivyde pegylated liposomal) with 5-fluorouracil and leucovorin[5]EMA authorisednot biomarker-specific; after progression following gemcitabine-based therapy. · EMA central authorisation does not establish reimbursement, access, or patient-specific suitability in each member state. Confidence/conflicts: high for EMA authorised indication; no conflict identified.
  • irinotecan hydrochloride trihydrate pegylated liposomal (Onivyde pegylated liposomal) with oxaliplatin, 5-fluorouracil, and leucovorin[5]EMA authorisednot biomarker-specific; first-line adult metastatic adenocarcinoma of the pancreas. · EMA central authorisation does not determine member-state reimbursement, center access, or individual suitability. Germany and France reimbursement/benefit assessment should be checked separately. Confidence/conflicts: high for EMA authorised indication; no conflict identified.
  • irinotecan liposomal pegylated / pegylated liposomal irinotecan (Onivyde) with 5-fluorouracil and leucovorin[6]Approvednot biomarker-specific; metastatic pancreatic adenocarcinoma after progression following treatment including gemcitabine. · HAS notes limitations in comparator choice and tolerability. This is a French HTA/reimbursement-context source, not a statement of individual suitability. Confidence/conflicts: high for HAS opinion; no conflict identified.
  • olaparib (Lynparza)[7]EMA authorisedgermline BRCA1/2 mutation; maintenance after a minimum of 16 weeks of first-line platinum treatment without progression. · EMA product information requires germline BRCA1/2 confirmation with a validated test; national reimbursement and access differ by member state. Confidence/conflicts: high for EMA authorised indication; no conflict identified.
  • olaparib (Lynparza)[8]Approvedgermline BRCA1/2 mutation; maintenance after at least 16 weeks of first-line platinum treatment without progression, when continuation of platinum-based chemotherapy is not suitable. · HAS rates clinical benefit moderate in the restricted subgroup and no clinical added value; outside the precise subgroup, HAS says the clinical benefit is insufficient for public funding. Confidence/conflicts: high for HAS reimbursement/care-pathway position; no conflict identified.
  • olaparib (Lynparza)[9]G-BA benefit assessmentgermline BRCA1/2 mutation; maintenance after a minimum of 16 weeks of platinum treatment within first-line chemotherapy without progression. · This is a G-BA courtesy translation; the German original is legally binding. "Additional benefit not proven" is a benefit-assessment conclusion, not a statement that the medicine lacks marketing authorisation. Confidence/conflicts: high for G-BA courtesy translation; German original legally binding. No conflict identified.
  • pegylated liposomal irinotecan (Onivyde pegylated liposomal) with oxaliplatin, 5-fluorouracil, and leucovorin[10]HAS reimbursement opinionnot biomarker-specific; metastatic adenocarcinoma of the pancreas; first-line context is implied by the EMA indication and HAS linked 2025 opinion summary but should be confirmed in the detailed French opinion before patient-facing reuse. · The fetched HAS index page gives the favourable-opinion summary but not the full detailed indication text in English. Confirm the detailed 2025 opinion and French reimbursement criteria before surfacing beyond link-only summary. Confidence/conflicts: medium-high; favourable reimbursement signal is clear, but detailed indication text should be fetched from the linked opinion for final patient-facing copy. No conflict identified.

United Kingdom

  • FOLFIRINOX chemotherapy regimen[11]NICE recommendednot biomarker-specific; first-line metastatic pancreatic cancer; ECOG performance status 0 to 1. · NICE notes off-label use in February 2018. This is a guideline recommendation and does not establish individual suitability, toxicity tolerance, or local prescribing details. Confidence/conflicts: high for NICE guideline support; no conflict identified.
  • larotrectinib (Vitrakvi)[12]ApprovedNTRK gene fusion; locally advanced or metastatic NTRK fusion-positive solid tumors, or surgery-morbid context, with no satisfactory treatment options. · This is histology-independent and Cancer Drugs Fund-managed access, not pancreatic-specific routine commissioning for all PDAC. Confirmation of NTRK fusion and CDF criteria is necessary. Confidence/conflicts: medium-high; solid-tumor recommendation is clear, but pancreatic applicability depends on rare NTRK fusion and managed-access criteria. No conflict identified.
  • nab-paclitaxel / paclitaxel as albumin-bound nanoparticles with gemcitabine[13]NICE recommendednot biomarker-specific; untreated metastatic adenocarcinoma of the pancreas. · Recommendation is restricted by suitability of other combination chemotherapy and a patient access scheme; it is not a broad first-line recommendation for all metastatic PDAC. Confidence/conflicts: high for NICE recommendation; no conflict identified.
  • resectional surgery, including pylorus-preserving resection when tumor can be adequately resected[11]NICE recommendednot biomarker-specific; surgery for head of pancreas cancer when resection is being undertaken and adequate resection is possible. · NICE guidance is not a statement that a person is operable. Resectability, fitness, staging, and local MDT review remain central. Confidence/conflicts: high for NICE guideline support; no conflict identified.

Japan

  • FOLFIRINOX chemotherapy[14]Standard option (per International Journal of Clinical Oncology / Japan Pancreas Society)not biomarker-specific; first-line chemotherapy for pancreatic cancer with distant metastases. · This is guideline evidence from an English synopsis, not a drug label or reimbursement rule. Fitness, organ function, and local regimen availability require Japanese treating-team confirmation. Confidence/conflicts: high for guideline recommendation; no conflict identified.
  • endoscopic biliary drainage/stenting, covered metallic stents, gastrointestinal stenting or surgical gastrojejunostomy in selected contexts, and multidisciplinary palliative/supportive care[14]Standard option (per International Journal of Clinical Oncology / Japan Pancreas Society)not biomarker-specific; obstructive jaundice, gastrointestinal obstruction, and advanced pancreatic cancer supportive-care contexts. · These are symptom/anatomy-specific supportive options. Procedure choice depends on anatomy, prognosis, local expertise, and patient goals. Confidence/conflicts: high for guideline support; no conflict identified.
  • gemcitabine hydrochloride plus nab-paclitaxel[14]Standard option (per International Journal of Clinical Oncology / Japan Pancreas Society)not biomarker-specific; first-line chemotherapy for pancreatic cancer with distant metastases. · This is guideline support, not a patient-specific regimen selection. Adverse effects, neuropathy risk, performance status, and local coverage require confirmation. Confidence/conflicts: high for guideline recommendation; no conflict identified.
  • olaparib (Lynparza)[15]PMDA-approved (Japan)BRCA mutation-positive; maintenance after chemotherapy including platinum-based antineoplastic drugs. · PMDA review report confirms the indication text in the label context; exact current package insert, companion diagnostic requirements, and insurance criteria should be checked in Japan. Confidence/conflicts: high for indication existence using PMDA review text; current-label and reimbursement details remain follow-up gaps. No conflict identified.
  • radiotherapy or chemoradiotherapy approaches, including fluoropyrimidine or gemcitabine with radiotherapy in locally advanced unresectable disease and radiotherapy for painful bone metastases[14]Standard option (per International Journal of Clinical Oncology / Japan Pancreas Society)not biomarker-specific; locally advanced unresectable pancreatic cancer scheduled for chemoradiotherapy; painful bone metastases in advanced disease; selected recurrence contexts. · The guideline distinguishes settings and recommendation strengths; radiotherapy is not described as universal for all PDAC. Local radiation expertise and goals of care matter. Confidence/conflicts: high for guideline support by setting; no conflict identified.

Russia

  • FOLFIRINOX-type chemotherapy; gemcitabine plus albumin-bound paclitaxel; gemcitabine monotherapy in less-fit patients; platinum-containing combinations in BRCA/PALB2 contexts[16]Standard option (per MedElement clinical recommendations portal)BRCA or PALB2 mutation status affects platinum-containing regimen preference in source; Preoperative/induction therapy for borderline resectable or unresectable non-metastatic disease; first-line metastatic therapy; less-fit metastatic contexts. · Regimen choice depends on ECOG/performance status, renal and liver function, tumor complications, age, comorbidities, and toxicity risks. This entry does not establish reimbursement or brand-specific availability. Confidence/conflicts: Medium-high for guideline role; reimbursement and individual access source-pending. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Pancreatic enzyme replacement, glucose monitoring/correction, biliary drainage when obstructive jaundice requires minimally invasive drainage, rehabilitation and symptom-directed supportive care[16]Standard option (per MedElement clinical recommendations portal)Not biomarker-selected; Postoperative and advanced-disease supportive-care contexts. · Supportive care depends on symptoms, nutrition, endocrine status, obstruction, infection, and access to gastroenterology, endocrinology, rehabilitation, and interventional endoscopy/radiology. Confidence/conflicts: Medium-high for supportive guideline content; product availability and individualized need not inferred. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Radiation therapy or chemoradiation only in selected study/individualized contexts; continuation or maintenance chemotherapy when unresectability persists[16]Standard option (per MedElement clinical recommendations portal)Not biomarker-selected; Borderline resectable or unresectable non-metastatic pancreatic cancer after induction therapy assessment. · This is a cautionary guideline cell: it records a restricted/non-routine role for radiation rather than routine availability. Decisions depend on restaging, response, tolerability, and clinical-trial access. Confidence/conflicts: Medium-high for guideline restriction; local clinical-trial options not established. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Radiation therapy or chemoradiation only in selected study/individualized contexts; continuation or maintenance chemotherapy when unresectability persists[16]Standard option (per MedElement clinical recommendations portal)Not biomarker-selected; Borderline resectable or unresectable non-metastatic pancreatic cancer after induction therapy assessment. · This is a cautionary guideline cell: it records a restricted/non-routine role for radiation rather than routine availability. Decisions depend on restaging, response, tolerability, and clinical-trial access. Confidence/conflicts: Medium-high for guideline restriction; local clinical-trial options not established. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Surgical treatment, including resection approaches appropriate to tumor location, with perioperative or adjuvant chemotherapy context[17]Standard option (per MedElement clinical recommendations portal)Not biomarker-selected; Resectable stage I-III contexts; perioperative/adjuvant settings as described by the guideline. · Resectability depends on vascular involvement, metastatic evaluation, CA 19-9 and other risk factors, performance status, surgical expertise, and multidisciplinary review. Russian-language clinical text requires human review. Confidence/conflicts: Medium-high for Russian guideline content; center-level access and Ministry-hosted original remain follow-up gaps. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Surgical treatment, including resection approaches appropriate to tumor location, with perioperative or adjuvant chemotherapy context[17]Standard option (per MedElement clinical recommendations portal)Not biomarker-selected; Resectable stage I-III contexts; perioperative/adjuvant settings as described by the guideline. · Resectability depends on vascular involvement, metastatic evaluation, CA 19-9 and other risk factors, performance status, surgical expertise, and multidisciplinary review. Russian-language clinical text requires human review. Confidence/conflicts: Medium-high for Russian guideline content; center-level access and Ministry-hosted original remain follow-up gaps. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.

Thailand

  • Pegylated liposomal irinotecan (Onivyde) with fluorouracil and leucovorin[18]ApprovedUGT1A1 status is a safety/pharmacogenetic consideration in the source; not a tumor-selection biomarker; After progression following gemcitabine-based therapy in metastatic pancreatic adenocarcinoma. · Thai NDI prescribing document supports indication text but does not establish reimbursement, formulary access, or center availability. Source warns that liposomal irinotecan is not interchangeable with non-liposomal irinotecan; toxicity monitoring is described in the label. Confidence/conflicts: High for Thai NDI prescribing-document indication; reimbursement not established.

출처

  1. National Cancer Institute (NCI) — national cancer agency evidence summary · national cancer agency evidence summary
  2. U.S. Food and Drug Administration (FDA) — drug label / prescribing information · drug label / prescribing information
  3. U.S. Food and Drug Administration (FDA) — drug label / prescribing information · drug label / prescribing information
  4. U.S. Food and Drug Administration (FDA) — regulator accelerated approval notice · regulator accelerated approval notice
  5. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  6. Haute Autorité de Santé (HAS) — national HTA/reimbursement opinion · national HTA/reimbursement opinion
  7. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  8. Haute Autorité de Santé (HAS) — national HTA/reimbursement opinion · national HTA/reimbursement opinion
  9. Gemeinsamer Bundesausschuss (G-BA) — national benefit assessment justification / courtesy translation · national benefit assessment justification / courtesy translation
  10. Haute Autorité de Santé (HAS) — national HTA/reimbursement opinion index · national HTA/reimbursement opinion index
  11. National Institute for Health and Care Excellence (NICE) — national guideline · national guideline
  12. National Institute for Health and Care Excellence (NICE) — technology appraisal / Cancer Drugs Fund recommendation · technology appraisal / Cancer Drugs Fund recommendation
  13. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
  14. International Journal of Clinical Oncology / Japan Pancreas Society — peer-reviewed English guideline synopsis · peer-reviewed English guideline synopsis
  15. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator review report · regulator review report
  16. MedElement clinical recommendations portal — Russian clinical guideline mirror / chemotherapy recommendations · Russian clinical guideline mirror / chemotherapy recommendations
  17. MedElement clinical recommendations portal — Russian clinical guideline mirror / treatment recommendations · Russian clinical guideline mirror / treatment recommendations
  18. 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.