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Gastric / gastro-oesophageal junction cancer: 국가별 선택지

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선택지 정리됨고형암최종 확인 2026.06

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임상시험 검색어

Gastric / gastro-oesophageal junction 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

  • fam-trastuzumab deruxtecan-nxki (Enhertu)[1]ApprovedHER2-positive defined as IHC 3+ or IHC 2+/ISH positive; after a prior trastuzumab-based regimen in locally advanced or metastatic disease. · The label directs HER2-based patient selection and says to reassess HER2 status if feasible after prior trastuzumab-based therapy and before treatment with ENHERTU. This cycle did not assess institutional infusion access or payer coverage.
  • nivolumab and hyaluronidase-nvhy (Opdivo Qvantig) monotherapy or with fluoropyrimidine/platinum chemotherapy, depending on indication[2]Approvedresidual pathologic disease after neoadjuvant chemoradiotherapy for adjuvant cell; PD-L1 >= 1 for first-line ESCC and gastric/GEJ/esophageal adenocarcinoma cells in the fetched Qvantig label; adjuvant after neoadjuvant chemoradiotherapy and complete resection with residual disease; first-line unresectable advanced/metastatic ESCC; advanced/metastatic gastric-GEJ-esophageal adenocarcinoma. · This label source is for subcutaneous Opdivo Qvantig and includes formulation-specific limitations, including not being indicated with ipilimumab for unresectable advanced/metastatic ESCC. Intravenous Opdivo label should be checked separately where formulation matters. Confidence/conflicts: medium-high; current label supports subcutaneous Opdivo Qvantig indications, but IV Opdivo should be checked separately for formulation-specific use. No conflict identified.
  • pembrolizumab (Keytruda) plus fluoropyrimidine- and platinum-containing chemotherapy[3]FDA-approvedHER2-negative; PD-L1 CPS greater than or equal to 1 by FDA-authorized test; first-line treatment of locally advanced unresectable or metastatic disease. · The label is limited to HER2-negative disease with PD-L1 CPS greater than or equal to 1 by an FDA-authorized test. This cycle did not compare it against non-pembrolizumab first-line U.S. options or payer coverage.
  • pembrolizumab (Keytruda) plus platinum- and fluoropyrimidine-based chemotherapy[3]FDA-approvedPD-L1 CPS >= 1 for combination therapy; GEJ tumours with epicenter 1 to 5 cm above the GEJ; locally advanced or metastatic disease not amenable to surgery or definitive chemoradiation; combination chemotherapy setting. · Requires PD-L1 CPS >= 1 by an FDA-authorized test for the combination indication. This label wording should be checked against the current FDA-approved prescribing information before patient-facing reuse. Confidence/conflicts: high for current label wording; no conflict identified.
  • pembrolizumab (Keytruda) plus trastuzumab plus fluoropyrimidine- and platinum-containing chemotherapy[3]FDA-approvedHER2-positive; PD-L1 CPS greater than or equal to 1 by FDA-authorized test; first-line treatment of locally advanced unresectable or metastatic disease. · The label requires both HER2-positive disease and PD-L1 CPS greater than or equal to 1 by an FDA-authorized test. This cycle did not assess payer coverage, infusion-center access, or regimen fit for a specific chemotherapy backbone.
  • pembrolizumab (Keytruda) single agent[3]FDA-approvedsquamous cell histology; PD-L1 CPS >= 10; after one or more prior lines of systemic therapy. · Applies to squamous cell histology and PD-L1 CPS >= 10. It is not the same as the first-line chemotherapy-combination indication. Confidence/conflicts: high for current label wording; no conflict identified.
  • ramucirumab (Cyramza) as a single agent or with paclitaxel[4]Approvedno biomarker gate in the U.S. label; after disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. · The label does not require a biomarker but does require prior fluoropyrimidine- or platinum-containing chemotherapy exposure with progression on or after that treatment. This cycle did not separate monotherapy versus paclitaxel-combination selection logic beyond the label language.
  • zolbetuximab-clzb (Vyloy) plus fluoropyrimidine- and platinum-containing chemotherapy[5]FDA-approvedHER2-negative; Claudin-18.2-positive defined in the label as at least 75% of tumor cells with moderate to strong membranous CLDN18 staining by an FDA-approved test; first-line treatment of locally advanced unresectable or metastatic disease. · Patient selection is narrower than "CLDN18.2-positive" shorthand because the label specifies the at-least-75%-of-tumor-cells moderate-to-strong membranous staining threshold. The label also highlights severe nausea, vomiting, and infusion/hypersensitivity risks.

European Union

  • nivolumab (Opdivo) monotherapy[6]EMA authorisedresidual pathologic disease after prior neoadjuvant chemoradiotherapy; adjuvant treatment after prior neoadjuvant chemoradiotherapy with residual pathologic disease. · EMA central authorisation does not establish national reimbursement or local access. The source wording is not limited to a specific histology in the cited indication line. Confidence/conflicts: high for EMA central indication; local reimbursement unverified. No conflict identified.
  • nivolumab (Opdivo) plus fluoropyrimidine- and platinum-based combination chemotherapy[6]EMA authorisedHER2-negative; PD-L1 CPS >= 5; first-line advanced or metastatic adenocarcinoma. · This is an adenocarcinoma indication and should not be conflated with oesophageal squamous cell carcinoma indications. EMA authorisation does not determine Germany/France reimbursement. Confidence/conflicts: high for EMA central indication; local reimbursement unverified. No conflict identified.
  • pembrolizumab (Keytruda) monotherapy[7]EMA authorisedMSI-H or dMMR; unresectable or metastatic gastric cancer after progression on or following at least one prior therapy. · This tissue-agnostic-like non-colorectal MSI-H/dMMR indication is specifically listed for gastric, small intestine, or biliary cancer. Confirm biomarker status and prior-therapy context. Confidence/conflicts: high for EMA indication scope; no conflict identified.
  • pembrolizumab (Keytruda) plus fluoropyrimidine and platinum-containing chemotherapy[7]EMA authorisedHER2-negative; PD-L1 CPS >= 1; first-line locally advanced unresectable or metastatic disease. · Requires HER2-negative disease and PD-L1 CPS >= 1 as stated by EMA. Country-level reimbursement and formulary access are separate from EMA central authorisation. Confidence/conflicts: high for EMA indication scope; no conflict identified.
  • pembrolizumab (Keytruda) plus trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy[7]EMA authorisedHER2-positive; PD-L1 CPS >= 1; first-line locally advanced unresectable or metastatic disease. · Requires HER2-positive disease and PD-L1 CPS >= 1 as stated by EMA. EMA central authorisation does not establish reimbursement or access in a particular member state. Confidence/conflicts: high for EMA indication scope; no conflict identified.
  • ramucirumab (Cyramza) plus paclitaxel; ramucirumab monotherapy when paclitaxel combination is not appropriate[8]EMA authoriseddisease progression after prior platinum and fluoropyrimidine chemotherapy for combination therapy; after prior platinum or fluoropyrimidine chemotherapy when paclitaxel is not appropriate for monotherapy. · EMA central indication does not guarantee reimbursement in each member state. This entry does not imply paclitaxel suitability or individual candidacy. Confidence/conflicts: high for EMA indication scope; no conflict identified.
  • zolbetuximab (Vyloy) plus fluoropyrimidine- and platinum-containing chemotherapy[9]EMA authorisedHER2-negative; Claudin (CLDN) 18.2-positive; first-line locally advanced unresectable or metastatic disease. · EMA notes Vyloy is under additional monitoring and is an orphan medicine. Requires HER2-negative and CLDN18.2-positive tumour status. Confidence/conflicts: high for EMA indication scope; no conflict identified.

United Kingdom

  • nivolumab (Opdivo)[10]Approvedresidual disease after previous neoadjuvant chemoradiotherapy; adjuvant treatment after complete resection and previous neoadjuvant chemoradiotherapy with residual disease. · NICE notes treatment choice depends on factors including histology, tumour size/location, patient preference, and treatment suitability; commercial arrangement applies. Confidence/conflicts: high for NICE recommendation; devolved/private access outside NICE context not verified. No conflict identified.
  • nivolumab (Opdivo) plus platinum- and fluoropyrimidine-based chemotherapy[11]ApprovedHER2-negative; PD-L1 CPS >= 5; untreated advanced or metastatic adenocarcinoma. · This cell applies to adenocarcinoma and should not be generalized to squamous-cell disease. NICE describes usual chemotherapy backbones as XELOX or FOLFOX in its rationale. Confidence/conflicts: high for NICE recommendation; devolved/private access outside NICE context not verified. No conflict identified.
  • nivolumab (Opdivo) with platinum- and fluoropyrimidine-based chemotherapy[11]ApprovedPD-L1 CPS >= 5; HER2-negative; untreated advanced or metastatic disease. · NICE states usual treatment is palliative chemotherapy and that nivolumab is recommended under the commercial arrangement. This entry includes gastric/GEJ because NICE TA857 covers gastric, GEJ, and oesophageal adenocarcinoma. Confidence/conflicts: high for NICE recommendation scope; no conflict identified.
  • oesophago-gastric clinical nurse specialist access; psychosocial support; specialist dietetic support; enteral/parenteral nutrition after radical surgery; rapid MDT access for recurrence symptoms[12]NICE recommendedacross radical treatment, palliative care, postoperative nutrition, and symptom-triggered follow-up. · These are supportive-care service and follow-up recommendations; they do not replace oncology treatment planning or imply routine imaging surveillance solely to detect recurrence. Confidence/conflicts: high for NICE guideline wording; local service availability not verified. No conflict identified.
  • pembrolizumab (Keytruda) with platinum- and fluoropyrimidine-based chemotherapy[13]ApprovedPD-L1 CPS >= 1; HER2-negative; untreated locally advanced unresectable or metastatic disease. · NICE recommendation is conditional on the commercial arrangement and applies within the marketing authorisation. Biomarker requirements are HER2-negative and PD-L1 CPS >= 1. Confidence/conflicts: high for NICE recommendation scope; no conflict identified.
  • perioperative chemotherapy for radical gastric surgery; palliative combination chemotherapy; palliative stenting/radiotherapy/local tumour treatment; nutritional and dietitian support[12]NICE recommendedradical gastric surgery context; untreated advanced palliative setting; obstruction and nutrition-support contexts. · NICE frames palliative chemotherapy around performance status and comorbidities, and obstruction interventions around fitness, prognosis, and disease extent. This is not individualized eligibility. Confidence/conflicts: high for NICE NG83 recommendation scope; no conflict identified.
  • perioperative chemotherapy or chemoradiotherapy before surgery; palliative combination chemotherapy with fluoropyrimidine/platinum doublet or fluoropyrimidine/platinum/epirubicin triplet options[12]NICE recommendedHER2 testing recommended for advanced oesophago-gastric adenocarcinoma; preoperative/perioperative localised adenocarcinoma; untreated advanced oesophago-gastric cancer. · Advanced palliative chemotherapy recommendation is performance-status and comorbidity dependent. HER2 testing is recommended for advanced oesophago-gastric adenocarcinoma, but this finding does not imply HER2-targeted eligibility. Confidence/conflicts: high for NICE guideline wording; regimen choice and fitness not inferred. No conflict identified.
  • self-expanding stents; radiotherapy; local tumour treatment; best supportive care[12]NICE recommendedpalliative management / luminal obstruction; non-metastatic disease not suitable for surgery when high-dose radiotherapy field is not feasible. · NICE says not to routinely offer external beam radiotherapy after stenting, except to consider it for prolonged post-interventional bleeding or known bleeding disorder. Choice depends on symptoms, nutrition, performance status, prognosis, and MDT judgement. Confidence/conflicts: high for NICE guideline wording; individual symptom-management suitability not inferred. No conflict identified.
  • trastuzumab with cisplatin and capecitabine or fluorouracil[12]NICE recommendedHER2-positive; untreated HER2-positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction per the linked NICE appraisal. · NICE NG83 also recommends HER2 testing for advanced oesophago-gastric adenocarcinoma. This cell does not include pembrolizumab-trastuzumab, which NICE TA983 separately does not recommend for routine NHS use. Confidence/conflicts: high for NICE NG83 recommendation; pembrolizumab-trastuzumab is separately not recommended by NICE TA983 and is noted as a caveat.
  • trifluridine-tipiracil (Lonsurf)[14]Approvedafter two or more treatment regimens. · NICE states standard treatment for most people after two or more treatments is best supportive care and the recommendation depends on the commercial arrangement. Confidence/conflicts: high for NICE recommendation scope; no conflict identified.

Japan

  • nivolumab (Opdivo) with other antineoplastic agents including fluoropyrimidine/platinum chemotherapy[15]PMDA-approved (Japan)HER2-negative; PD-L1 expression should be considered per PMDA discussion; previously untreated unresectable, advanced or recurrent gastric cancer; HER2-negative population emphasized in PMDA's clinical-positioning discussion. · PMDA states Japanese original text takes precedence over English translation. PMDA also says it is difficult to conclude favorable risk-benefit in CPS <5 and that addition of nivolumab should be determined carefully taking PD-L1 expression into account. Confidence/conflicts: medium-high; PMDA English translation supports approval context, but Japanese original controls and PD-L1 subgroup caution is explicit. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • pembrolizumab (Keytruda) monotherapy[16]PMDA-approved (Japan)MSI-High; advanced or recurrent MSI-High solid tumours after cancer chemotherapy and refractory/intolerant to standard treatments. · This is an inference from PMDA's tumour-agnostic solid-tumour indication to gastric cancer as a solid tumour; the source does not name gastric cancer in the indication. PMDA required post-marketing surveillance for MSI-High solid tumours except colorectal cancer. Japanese original takes precedence over English translation. Confidence/conflicts: medium; PMDA verifies MSI-High solid-tumour approval, but gastric applicability is inferred from the solid-tumour category and should be checked against the current Japanese label. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • trastuzumab deruxtecan (Enhertu)[17]PMDA-approved (Japan)HER2-positive; unresectable advanced or recurrent HER2-positive gastric cancer after at least two chemotherapy regimens including trastuzumab. · PMDA noted adverse events requiring particular attention, and this entry does not provide dosing or eligibility. Japanese original label should be checked for current wording before patient-facing reuse. Confidence/conflicts: high for PMDA review-report indication context; no conflict identified. Availability/reimbursement outside the approving regulator not established.
  • zolbetuximab (Vyloy) in combination with other antineoplastic agents[18]PMDA-approved (Japan)CLDN18.2-positive; HER2-negative in pivotal efficacy discussion; unresectable advanced or recurrent gastric cancer; efficacy discussion specifies no prior chemotherapy for the CLDN18.2-positive/HER2-negative population. · PMDA required a risk management plan and further investigation of nausea/vomiting through post-marketing surveillance. CLDN18.2 positivity should be confirmed by adequately experienced pathologists or qualified laboratories per PMDA discussion. Confidence/conflicts: high for PMDA approval-review scope; no conflict identified. Availability/reimbursement outside the approving regulator not established.

Korea

  • zolbetuximab (Vyloy)[19]MFDS-approved (Korea)CLDN18.2-positive; HER2-negative inferred from global Vyloy indication context; Astellas page provides approval location/date but not full Korea label wording in the fetched content. · Company medical-information source intended for U.S. healthcare professionals; product labeling may vary by country. MFDS primary label remains a follow-up gap before patient-facing reuse. Confidence/conflicts: medium; approval date is company-sourced with MFDS citation, but MFDS page fetch timed out. No conflict identified. Availability/reimbursement outside the approving regulator not established.

China

Thailand

  • zolbetuximab (Vyloy)[19]FDA-approvedCLDN18.2-positive; HER2-negative inferred from global Vyloy indication context; Astellas page provides approval location/date but not full Thai label wording in the fetched content. · Company medical-information source intended for U.S. healthcare professionals; product labeling may vary between countries. Thai FDA primary label remains a follow-up gap before patient-facing reuse. Confidence/conflicts: medium; approval date is company-sourced with Thai FDA citation, but Thai FDA primary label was not fetched. No conflict identified. Availability/reimbursement outside the approving regulator not established.

출처

  1. DailyMed / National Library of Medicine — official U.S. prescribing information / label repository · official U.S. prescribing information / label repository
  2. DailyMed / U.S. National Library of Medicine — official drug label · official drug label
  3. DailyMed / National Library of Medicine — official U.S. prescribing information / label repository · official U.S. prescribing information / label repository
  4. DailyMed / National Library of Medicine — official U.S. prescribing information / label repository · official U.S. prescribing information / label repository
  5. DailyMed / National Library of Medicine — official U.S. prescribing information / label repository · official U.S. prescribing information / label repository
  6. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  7. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  8. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  9. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  10. National Institute for Health and Care Excellence (NICE) — national HTA/guideline recommendation · national HTA/guideline recommendation
  11. National Institute for Health and Care Excellence (NICE) — national HTA/guideline recommendation · national HTA/guideline recommendation
  12. National Institute for Health and Care Excellence (NICE) — national guideline · national guideline
  13. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
  14. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
  15. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator review report PDF / English translation · regulator review report PDF / English translation
  16. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator review report PDF / English translation · regulator review report PDF / English translation
  17. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator review report PDF / English translation · regulator review report PDF / English translation
  18. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator review report PDF / English translation · regulator review report PDF / English translation
  19. Astellas Medical Information — manufacturer medical-information page citing regulator product information · manufacturer medical-information page citing regulator product information
  20. China National Medical Products Administration (NMPA) / CCFDIE — regulator approval notice · regulator approval notice

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.