Phase II Study Comparing Induction Chemo-Immunotherapy Followed by Radiotherapy Versus Concurrent Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma

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.

Induction Chemo-Immunotherapy + Radiotherapy vs Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma