RecruitingPhase 2NCT06912074

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

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

Sponsor

Sun Yat-sen University

Enrollment

134 participants

Start Date

Apr 5, 2025

Study Type

INTERVENTIONAL

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two radiation schedules — a shorter course of higher daily doses (hypofractionated) versus the standard longer course — combined with chemotherapy and immunotherapy for people with locally advanced esophageal squamous cell carcinoma (a type of esophageal cancer) that cannot be surgically removed. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with esophageal squamous cell carcinoma confirmed by biopsy - Your cancer is locally advanced and considered unresectable (stage II–IVB, with spread limited to nearby lymph nodes only) - You have not had prior chemotherapy, radiation, surgery, or immunotherapy for this cancer - You are physically able to take oral medications and your overall health is good - Your lung, blood, kidney, and liver function meet minimum requirements **You may NOT be eligible if...** - You have previously received treatments for this cancer - You are currently pregnant or breastfeeding - You are taking immunosuppressive drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInduction chemoimmunotherapy

All patients will receive two cycles of induction therapy with albumin-bound paclitaxel and cisplatin combined with toripalimab.

RADIATIONHypofractionated Radiation Therapy

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.

RADIATIONConventional Fractionated Radiation Therapy

Patients will receive a total dose of 5000 cGy in 25 fractions, with 200 cGy per fraction.

DRUGConcurrent Chemotherapy

Capecitabine oral administration, 1000 mg/m², twice daily

Locations(1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06912074

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