A Phase 2 interventional study of Induction chemoimmunotherapy and Hypofractionated Radiation Therapy in Esophageal Squamous Cell Carcinoma (ESCC), sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-17.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
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.
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. In this study, patients will receive induction therapy with albumin-bound paclitaxel and cisplatin combined with toripalimab. After induction therapy, they will be randomly assigned to receive either definitive hypofractionated concurrent chemoradiotherapy or conventional fractionated concurrent chemoradiotherapy. Following the completion of treatment, patients will undergo regular follow-up to assess efficacy and safety.
645 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 275 are open to participants now.
This study's planned enrollment of 134 is above the median of 65 across 539 interventional studies indexed under Esophageal Squamous Cell Carcinoma.
Browse Esophageal Squamous Cell Carcinoma studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for Induction Treatment:
Exclusion Criteria for Concurrent Chemoradiotherapy After Induction Treatment:
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.
Drug: Induction chemoimmunotherapy · Radiation: Hypofractionated Radiation Therapy · Drug: Concurrent Chemotherapy
Patients in this group will receive a total dose of 5000 cGy in 25 fractions, with 200 cGy per fraction.
Drug: Induction chemoimmunotherapy · Radiation: Conventional Fractionated Radiation Therapy · Drug: Concurrent Chemotherapy
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
Progression-free survival rate
The proportion of patients who remain free from disease progression during a defined period after treatment initiation.
Time frame: 2 years
Overall survival rate
The proportion of patients who are still alive after a specified period of time, regardless of disease progression or relapse.
Time frame: 2 years
Clinical response rate
The percentage of patients who had partial remission or complete remission after therapy
Time frame: 2 months after radiotherapy
Rate of grade 3 or higher toxicities
The percentage of patients who develop grade 3 or higher toxicities. The toxicities are evaluated based on Common Terminology Criteria for Adverse Events version 5.0. The values range from 1 to 5. A higher score means a worse outcome.
Time frame: 1 year after therapy
Distant metastasis-free survival rate
Time frame: 2 years
Locoregional recurrence-free survival rate
Time frame: 2 years
Plan to share: No
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