Phase II Trial Comparing Hypofractionated Versus Conventional Chemoradiotherapy After Induction Chemoimmunotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating two types of chemoradiotherapy to treat patients with unresectable locally advanced esophageal squamous cell carcinoma. This prospective, open-label, randomized phase II clinical trial compares the effectiveness and side effects of hypofractionated concurrent chemoradiotherapy versus conventional fractionated concurrent chemoradiotherapy after patients receive induction chemoimmunotherapy. The study aims to improve treatment outcomes for this challenging condition. All participants first receive two cycles of induction therapy combining albumin-bound paclitaxel, cisplatin, and toripalimab. Then, they are randomly assigned to one of two groups one group receives hypofractionated radiotherapy once daily, five days a week, followed by a radiotherapy boost if certain conditions are met the other group receives conventional fractionated radiotherapy with a total dose delivered in smaller daily fractions. Concurrent chemotherapy with oral capecitabine is also given during radiotherapy. During the study, patients will have tumor response and cardiopulmonary function assessments, including endoscopy and imaging, to guide treatment. Follow-up visits will monitor progression-free survival, overall survival, response rates, and treatment-related toxicities for up to two years. Safety and efficacy are carefully evaluated through clinical exams, laboratory tests, and imaging. Participation may last several years with regular visits for monitoring and outcome measurement.

Hypofractionated vs. Conventional Chemoradiotherapy After Induction Chemo-immunotherapy for Unresectable Esophageal Squamous Cell Carcinoma