Induction Chemo-Immunotherapy + Radiotherapy vs Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
2026년 4월 26일 업데이트: Second Affiliated Hospital of Zunyi Medical University
Efficacy and Safety of Induction Chemo-Immunotherapy Followed by Radiotherapy vs Concurrent Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Randomized, Two-Arm, Phase II Study
This is a prospective, randomized, phase II clinical study in patients with unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC).
Eligible patients will be randomly assigned in a 1:1 ratio to two treatment groups.
The experimental group will receive 3 cycles of induction therapy with PD-1 antibody plus chemotherapy, followed by radiotherapy, and then maintenance therapy with PD-1 antibody monotherapy.
The control group will receive concurrent chemoradiotherapy, followed by maintenance therapy with PD-1 antibody monotherapy.
The primary endpoints are the complete response (CR) rate at 3 months after radiotherapy (assessed by investigators) and the 1-year progression-free survival (PFS) rate.
Secondary endpoints include overall survival (OS), progression-free survival (PFS), duration of response, objective response rate (ORR), local-regional recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), quality of life, and safety profile.
연구 개요
상태
모병
상세 설명
This is a prospective, randomized, two-arm, phase II clinical trial investigating induction chemo-immunotherapy followed by sequential radiotherapy versus concurrent chemo-immunotherapy plus radiotherapy in patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC).
Current standard of care for unresectable locally advanced ESCC is definitive concurrent chemoradiotherapy. However, outcomes remain suboptimal, with high rates of local recurrence and distant metastasis. The addition of PD-1 inhibitors to concurrent chemoradiotherapy has shown promising activity in recent studies, but optimal sequencing and integration of immunotherapy with radiotherapy are still under investigation.
This trial is designed to evaluate whether an induction strategy with chemo-immunotherapy followed by radiotherapy can improve response rates and long-term survival compared to the standard concurrent approach. Patients will be randomized to receive either:
- Experimental arm: Three cycles of induction chemo-immunotherapy, followed by definitive thoracic radiotherapy, then maintenance immunotherapy for up to one year.
- Control arm: Concurrent chemo-immunotherapy plus definitive thoracic radiotherapy, followed by maintenance immunotherapy for up to one year.
The primary objective is to compare the efficacy of the two regimens in terms of complete response and progression-free survival. Safety, tolerability, and quality of life will also be assessed to support the risk-benefit profile of each strategy.
연구 유형
중재적
등록 (추정된)
92
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Jian-Guo Zhou, PhD
- 전화번호: +86-851-18212154044
- 이메일: jsdxzl@126.com
연구 장소
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Guizhou
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Zunyi, Guizhou, 중국, 563000
- 모병
- The Second Affiliated Hospital of Zunyi Medical University, Xinpu New District, Honghuagang District, Zunyi City, Guizhou Province
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연락하다:
- lei zhou, Master
- 전화번호: +86-851-18212154044
- 이메일: jsdxzl@126.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Histologically or cytologically confirmed unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function (bone marrow, liver, renal, cardiac) within 2 weeks prior to randomization
- Measurable or evaluable disease per RECIST 1.1
- Willing to provide written informed consent
Exclusion Criteria:
- Previous radiotherapy to the chest or previous systemic chemotherapy for ESCC
- History of other malignancies within the last 5 years (except cured basal cell carcinoma or cervical carcinoma in situ)
- Severe comorbidities (uncontrolled hypertension, NYHA class III-IV heart failure, active infection, etc.)
- Known hypersensitivity to any study drugs (paclitaxel, cisplatin/carboplatin, PD-1 antibody)
- Pregnant or lactating women
- Participation in another clinical trial within 30 days prior to randomization
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Experimental Group: Chemo-Immunotherapy Induction + Radiotherapy + PD-1 Maintenance
Patients receive 3 cycles of PD-1 antibody plus chemotherapy induction therapy, followed by thoracic radiotherapy (50.4Gy in 28 fractions), then PD-1 antibody maintenance therapy (200mg IV q3w, up to 1 year).
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Paclitaxel 150-175 mg/m² combined with cisplatin 75 mg/m² or carboplatin AUC 5 (maximum 600 mg), administered intravenously every 3 weeks for 3 cycles, concurrent with PD-1 antibody induction therapy for unresectable stage III-IVA esophageal squamous cell carcinoma.
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활성 비교기: Control Group: Concurrent Chemoradiotherapy + PD-1 Maintenance
Patients receive weekly paclitaxel + cisplatin/carboplatin concurrent with thoracic radiotherapy (50.4Gy in 28 fractions), then PD-1 antibody maintenance therapy (200mg IV q3w, up to 1 year).
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Paclitaxel 50 mg/m² combined with cisplatin 25 mg/m² or carboplatin AUC 5 (maximum 600 mg), administered intravenously once weekly for 5 cycles, concurrent with thoracic radiotherapy (50.4Gy in 28 fractions) for unresectable stage III-IVA esophageal squamous cell carcinoma.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Complete Response (CR) Rate at 3 Months After Radiotherapy (Investigator-Assessed)
기간: 3 months after completion of radiotherapy
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Proportion of patients achieving complete response (CR) per RECIST 1.1, assessed by investigators at 3 months after completion of radiotherapy
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3 months after completion of radiotherapy
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1-Year Progression-Free Survival (PFS) Rate
기간: 1 year after randomization
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Proportion of patients alive and without disease progression at 1 year after randomization
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1 year after randomization
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall Survival (OS)
기간: Up to 3 years after randomization
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Time from randomization to death from any cause
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Up to 3 years after randomization
|
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Progression-Free Survival (PFS)
기간: Up to 3 years after randomization
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Time from randomization to first documented disease progression or death from any cause, whichever occurs first
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Up to 3 years after randomization
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Duration of Response (DOR)
기간: Up to 3 years after randomization
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Time from first documentation of objective response (CR/PR) to first documented disease progression or death
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Up to 3 years after randomization
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Objective Response Rate (ORR)
기간: Up to 3 years after randomization
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Proportion of patients achieving CR or partial response (PR) per RECIST 1.1
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Up to 3 years after randomization
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Local Regional Failure-Free Survival (LRFS)
기간: Up to 3 years after randomization
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Time from randomization to first local or regional recurrence or death
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Up to 3 years after randomization
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Distant Metastasis-Free Survival (DMFS)
기간: Up to 3 years after randomization
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Time from randomization to first distant metastasis or death
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Up to 3 years after randomization
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Incidence of Treatment-Emergent Adverse Events (TEAEs)
기간: From first study treatment to 30 days after last treatment
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Incidence and severity of TEAEs (graded per CTCAE 5.0) during treatment and follow-up
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From first study treatment to 30 days after last treatment
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EORTC QLQ-OES18 Symptom Score Change
기간: Baseline, 3 months, 6 months, 12 months after radiotherapy
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Change in esophageal cancer-specific symptom score as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Oesophageal 18 (EORTC QLQ-OES18) from baseline to post-treatment follow-ups.
The scale ranges from 0 to 100, with higher scores indicating more severe symptoms and worse quality of life.
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Baseline, 3 months, 6 months, 12 months after radiotherapy
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EORTC QLQ-C30 Quality of Life Score Change
기간: Baseline, 3 months, 6 months, 12 months after radiotherapy.
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Change in quality of life score as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) from baseline to post-treatment follow-ups.
The scale ranges from 0 to 100, with higher scores indicating better quality of life.
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Baseline, 3 months, 6 months, 12 months after radiotherapy.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Lei Zhou, Master, The Second Affiliated Hospital of Zunyi Medical University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 1월 1일
기본 완료 (추정된)
2028년 1월 1일
연구 완료 (추정된)
2028년 6월 30일
연구 등록 날짜
최초 제출
2026년 3월 28일
QC 기준을 충족하는 최초 제출
2026년 4월 26일
처음 게시됨 (실제)
2026년 4월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 4월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 4월 26일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- KYLL-2025-143
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .