Actively Recruiting
Induction Chemo-Immunotherapy + Radiotherapy vs Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
Led by Second Affiliated Hospital of Zunyi Medical University · Updated on 2026-04-30
92
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Induction Chemo-Immunotherapy + Radiotherapy vs Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate bone marrow, liver, renal, and cardiac function within 2 weeks prior to randomization
- Measurable or evaluable disease according to RECIST 1.1
- Willing to provide written informed consent
You will not qualify if you...
- 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 such as uncontrolled hypertension, NYHA class III-IV heart failure, or active infection
- Known hypersensitivity to paclitaxel, cisplatin/carboplatin, or PD-1 antibody
- Pregnant or lactating women
- Participation in another clinical trial within 30 days prior to randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Zunyi Medical University, Xinpu New District, Honghuagang District, Zunyi City, Guizhou Province
Zunyi, Guizhou, China, 563000
Actively Recruiting
Research Team
J
Jian-Guo Zhou, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here