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선택지 정리됨

Esophageal cancer: 국가별 선택지

이 페이지는 한국어 임상 치료 설명을 새로 쓰지 않습니다. 권위 출처, 진료 전 정리 질문, 임상시험 검색어, 구축 상태를 보여주는 안전한 시작점입니다.

선택지 정리됨고형암최종 확인 2026.06

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국가별로 출처가 연결된 선택지와 함께, 진단명·단계·검사 결과·진료과·임상시험 검색어를 정리합니다.

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  • 이 항목은 원문 출처와 함께 의료진에게 확인하세요.
  • 이 항목은 원문 출처와 함께 의료진에게 확인하세요.
  • 이 항목은 원문 출처와 함께 의료진에게 확인하세요.
  • 이 항목은 원문 출처와 함께 의료진에게 확인하세요.

임상시험 검색어

Esophageal 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

  • nivolumab (Opdivo)[1]FDA-approvedafter prior fluoropyrimidine- and platinum-based chemotherapy. · FDA approval notice supports the 2020 post-chemotherapy ESCC indication; current formulation/route and label details should be checked in the latest prescribing information. Confidence/conflicts: high for FDA approval notice; no conflict identified.

European Union

  • nivolumab (Opdivo) monotherapy[2]EMA authorisedafter prior fluoropyrimidine- and platinum-based combination chemotherapy. · EMA central authorisation only; country-specific access and reimbursement remain separate checks. Confidence/conflicts: high for EMA central indication; local reimbursement unverified. No conflict identified.
  • nivolumab (Opdivo) plus fluoropyrimidine- and platinum-based combination chemotherapy[2]EMA authorisedtumour-cell PD-L1 expression >= 1%; first-line unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma. · EMA central authorisation does not establish national reimbursement, and the PD-L1 threshold is source-stated. Confidence/conflicts: high for EMA central indication; local reimbursement unverified. No conflict identified.
  • nivolumab (Opdivo) plus ipilimumab (Yervoy)[2]EMA authorisedtumour-cell PD-L1 expression >= 1%; first-line unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma. · EMA central authorisation does not establish country-specific reimbursement. The source specifies tumour-cell PD-L1 expression >= 1% for this indication. Confidence/conflicts: high for EMA central indication; local reimbursement unverified. No conflict identified.
  • pembrolizumab (Keytruda) plus platinum- and fluoropyrimidine-based chemotherapy[3]EMA authorisedPD-L1 CPS >= 10; first-line locally advanced unresectable or metastatic oesophageal carcinoma. · EMA central authorisation does not establish Germany/France reimbursement or local hospital access. PD-L1 CPS threshold is part of the stated indication. Confidence/conflicts: high for EMA central indication; Germany/France reimbursement not verified in this finding. No conflict identified.

United Kingdom

Japan

  • nivolumab (Opdivo)[7]PMDA-approved (Japan)not required by PMDA discussion; PMDA notes PD-L1 selection was not necessary for this post-chemotherapy nivolumab setting; after prior fluoropyrimidine- and platinum-based chemotherapy. · PMDA English translation is reference material; Japanese original takes precedence. PMDA notes clinical studies enrolled patients categorized as squamous cell carcinoma, with non-squamous use requiring physician judgement based on the evidence context. Confidence/conflicts: medium-high; PMDA supports the post-chemotherapy esophageal cancer indication but notes the enrolled clinical population was squamous-cell. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • nivolumab (Opdivo)[8]PMDA-approved (Japan)not achieved pathological complete response (pCR) after neoadjuvant therapy; adjuvant therapy after neoadjuvant therapy in patients without pCR. · PMDA English translation is reference material; Japanese original takes precedence. Source does not establish reimbursement or hospital formulary access. Confidence/conflicts: high for PMDA review-report indication; current Japanese package insert and reimbursement not checked in this finding. No conflict identified.
  • pembrolizumab (Keytruda)[9]PMDA-approved (Japan)PD-L1 positive; after progression following cancer chemotherapy. · PMDA English translation is reference material; Japanese original takes precedence. The source is a review report and does not establish reimbursement or local hospital formulary status. Confidence/conflicts: high for PMDA review-report indication; current Japanese package insert and reimbursement not checked in this finding. No conflict identified.

Korea

  • nivolumab (Opdivo) plus fluoropyrimidine- and platinum-containing chemotherapy[10]MFDS-approved (Korea)tumour-cell PD-L1 expression >= 1%; first-line unresectable advanced or metastatic esophageal squamous cell carcinoma. · This is a manufacturer announcement citing MFDS approval, not an MFDS-primary label or HIRA reimbursement source. Current Korea label and reimbursement status remain follow-up gaps. Confidence/conflicts: medium; MFDS approval is manufacturer-attributed and primary label/reimbursement were not fetched. No conflict identified.
  • nivolumab (Opdivo) plus ipilimumab (Yervoy)[10]MFDS-approved (Korea)tumour-cell PD-L1 expression >= 1%; first-line unresectable advanced or metastatic esophageal squamous cell carcinoma. · This is a manufacturer announcement citing MFDS approval, not an MFDS-primary label or HIRA reimbursement source. Current Korea label and reimbursement status remain follow-up gaps. Confidence/conflicts: medium; MFDS approval is manufacturer-attributed and primary label/reimbursement were not fetched. No conflict identified.

China

  • pembrolizumab (Keytruda) monotherapy[11]ApprovedPD-L1 CPS >= 10 by a fully validated test; second-line / following failure of one prior line of systemic therapy. · This is a manufacturer announcement attributing approval to NMPA, not an NMPA-primary label page. China label wording, reimbursement, and current availability need primary-source confirmation before patient-facing reuse. Confidence/conflicts: medium; NMPA approval is company-attributed and primary China label was not fetched. No conflict identified.
  • sintilimab (Tyvyt) plus cisplatin/paclitaxel or cisplatin/5-fluorouracil chemotherapy[12]NMPA-approved (China)not restricted by PD-L1 in the source's stated approval wording; first-line treatment. · This is a company/PR Newswire announcement attributing approval to NMPA CDE, not an NMPA-primary label. It states ORIENT-15 benefit regardless of PD-L1 expression, but local label and reimbursement should be checked directly. Confidence/conflicts: medium; NMPA approval is company-attributed and primary China label was not fetched. No conflict identified.

출처

  1. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  2. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  3. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  4. National Institute for Health and Care Excellence (NICE) — national guideline · national guideline
  5. National Institute for Health and Care Excellence (NICE) — national HTA/guideline recommendation · national HTA/guideline recommendation
  6. National Institute for Health and Care Excellence (NICE) — national HTA/guideline recommendation · national HTA/guideline recommendation
  7. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator review report · regulator review report
  8. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator review report · regulator review report
  9. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator review report · regulator review report
  10. Ono Pharmaceutical — manufacturer approval announcement citing MFDS · manufacturer approval announcement citing MFDS
  11. Merck — manufacturer approval announcement citing NMPA · manufacturer approval announcement citing NMPA
  12. Innovent Biologics / PR Newswire — manufacturer approval announcement citing NMPA CDE · manufacturer approval announcement citing NMPA CDE

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.