Actively Recruiting
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
Led by Second Affiliated Hospital of Zunyi Medical University · Updated on 2026-04-30
92
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two treatment approaches for patients with unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC), a serious form of esophageal cancer. This phase II clinical trial compares an induction chemo-immunotherapy followed by radiotherapy and maintenance immunotherapy with the current standard treatment of concurrent chemoradiotherapy plus maintenance immunotherapy. The purpose is to find out if the induction approach improves the complete response rate and progression-free survival, while also assessing safety and quality of life. Participants will be randomly assigned to one of two groups. The experimental group receives three cycles of PD-1 antibody combined with chemotherapy as induction therapy, followed by thoracic radiotherapy, then PD-1 antibody maintenance therapy for up to one year. The control group receives weekly chemotherapy with paclitaxel plus cisplatin or carboplatin concurrent with thoracic radiotherapy, followed by the same PD-1 antibody maintenance therapy schedule. Radiotherapy is given as 50.4 Gy in 28 fractions in both groups. During the study, participants will have assessments including imaging to measure tumor response, laboratory tests, and quality of life questionnaires at baseline and multiple timepoints after radiotherapy. Researchers will monitor complete response at 3 months post-radiotherapy and progression-free survival at 1 year. Additional outcomes include overall survival, duration of response, and safety evaluations. The total follow-up may last up to 3 years to track long-term effects and disease progression.
CONDITIONS
Brief 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 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
- Age between 18 and 75 years
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 (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
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 weeks
Participants in the experimental group receive three cycles of chemo-immunotherapy given every 3 weeks before radiotherapy.
3 visits (in-person, every 3 weeks)
Duration - Approximately 5 weeks
Participants in the control group receive weekly chemo-immunotherapy concurrently with radiotherapy.
5 weekly visits (in-person)
Duration - Approximately 5.5 weeks
Participants in the experimental group receive thoracic radiotherapy following induction chemo-immunotherapy.
Daily visits for radiotherapy sessions (Monday to Friday) for 5.5 weeks
Duration - Approximately 5.5 weeks
Participants in the control group receive thoracic radiotherapy concurrently with chemotherapy.
Daily visits for radiotherapy sessions (Monday to Friday) for 5.5 weeks
Duration - Up to 1 year
Participants receive PD-1 antibody maintenance therapy every 3 weeks for up to one year after radiotherapy.
Visits every 3 weeks for infusions during maintenance therapy
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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