At a glance
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Comparing Hypofractionated Concurrent Chemoradiotherapy Versus Conventional Fractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Prospective, Open-Label, Randomized Phase II Clinical Trial
In Brief
A Phase 2 clinical trial evaluating Induction chemoimmunotherapy, Hypofractionated Radiation Therapy, and 2 other interventions for Esophageal Squamous Cell Carcinoma (ESCC). Currently recruiting, targeting 134 participants across 1 site.
Detailed Summary
This is a prospective, open-label, randomized phase II clinical trial designed to compare the efficacy and toxicity of hypofractionated concurrent chemoradiotherapy versus conventional fractionated concurrent chemoradiotherapy following induction chemoimmunotherapy in patients with unresectable locally advanced esophageal squamous cell carcinoma.
Study Details
Timeline
Interventions
All patients will receive two cycles of induction therapy with albumin-bound paclitaxel and cisplatin combined with toripalimab.
All patients will receive hypofractionated radiotherapy once daily, five days per week, followed by a boost. Three weeks after the completion of the first phase of hypofractionated radiotherapy, tumor response and cardiopulmonary function will be evaluated. For patients who achieve a partial response, have no deep esophageal ulcers on endoscopy, and have cardiopulmonary function tolerating the radiotherapy boost, a second phase of radiotherapy will be planned using a new CT simulation and radiotherapy design. First Phase of Radiotherapy: Total dose of 2500 cGy in 5 fractions (500 cGy per fraction) Second Phase of Radiotherapy: Total dose of 2500 cGy in 10 fractions (250 cGy per fraction) The interval between the two phases of radiotherapy will be 28 days.
Patients will receive a total dose of 5000 cGy in 25 fractions, with 200 cGy per fraction.
Capecitabine oral administration, 1000 mg/m², twice daily