Induction Chemo-Immunotherapy + Radiotherapy vs Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
2026年4月26日 更新者：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.
研究概览
地位
招聘中
详细说明
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.
研究类型
介入性
注册 (估计的)
92
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jian-Guo Zhou, PhD
- 电话号码：+86-851-18212154044
- 邮箱：jsdxzl@126.com
学习地点
-
-
Guizhou
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Zunyi、Guizhou、中国、563000
- 招聘中
- The Second Affiliated Hospital of Zunyi Medical University, Xinpu New District, Honghuagang District, Zunyi City, Guizhou Province
-
接触：
- lei zhou, Master
- 电话号码：+86-851-18212154044
- 邮箱：jsdxzl@126.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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).
|
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.
|
|
有源比较器：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).
|
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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Complete Response (CR) Rate at 3 Months After Radiotherapy (Investigator-Assessed)
大体时间：3 months after completion of radiotherapy
|
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
大体时间：1 year after randomization
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Proportion of patients alive and without disease progression at 1 year after randomization
|
1 year after randomization
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival (OS)
大体时间：Up to 3 years after randomization
|
Time from randomization to death from any cause
|
Up to 3 years after randomization
|
|
Progression-Free Survival (PFS)
大体时间：Up to 3 years after randomization
|
Time from randomization to first documented disease progression or death from any cause, whichever occurs first
|
Up to 3 years after randomization
|
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Duration of Response (DOR)
大体时间：Up to 3 years after randomization
|
Time from first documentation of objective response (CR/PR) to first documented disease progression or death
|
Up to 3 years after randomization
|
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Objective Response Rate (ORR)
大体时间：Up to 3 years after randomization
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Proportion of patients achieving CR or partial response (PR) per RECIST 1.1
|
Up to 3 years after randomization
|
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Local Regional Failure-Free Survival (LRFS)
大体时间：Up to 3 years after randomization
|
Time from randomization to first local or regional recurrence or death
|
Up to 3 years after randomization
|
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Distant Metastasis-Free Survival (DMFS)
大体时间：Up to 3 years after randomization
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Time from randomization to first distant metastasis or death
|
Up to 3 years after randomization
|
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Incidence of Treatment-Emergent Adverse Events (TEAEs)
大体时间：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
|
From first study treatment to 30 days after last treatment
|
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EORTC QLQ-OES18 Symptom Score Change
大体时间：Baseline, 3 months, 6 months, 12 months after radiotherapy
|
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
大体时间：Baseline, 3 months, 6 months, 12 months after radiotherapy.
|
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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Lei Zhou, Master、The Second Affiliated Hospital of Zunyi Medical University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年1月1日
初级完成 (估计的)
2028年1月1日
研究完成 (估计的)
2028年6月30日
研究注册日期
首次提交
2026年3月28日
首先提交符合 QC 标准的
2026年4月26日
首次发布 (实际的)
2026年4月30日
研究记录更新
最后更新发布 (实际的)
2026年4月30日
上次提交的符合 QC 标准的更新
2026年4月26日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- KYLL-2025-143
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