Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Locally-advanced Esophageal Squamous Cell Cancer (RICE)

Study Overview
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Brief Summary
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This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of non-operative Locally Advanced Esophageal Cancer . The purpose of this study was to evaluate the efficacy and safety of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer.

Official Title
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A Phase 2 Trial of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer

Conditions
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Esophageal Squamous Cell Carcinomas, Concurrent Chemoradiotherapy, Immunotherapy, Chemotherapy

Intervention / Treatment
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* Drug: chemotherapy combined with PD-1 inhibitors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age:18-75 years of age; Histologically confirmed squamous cell carcinoma; locally-advanced ,medical inoperability, technical irresectability, or patient refusal to surgery; Eastern Cooperative Oncology Group (ECOG) performance status:0-2; Able to eat a semi-liquid diet; Less than 20% weight loss within 6 months; Adequate hepatic function, renal function, hematologic function and coagulation function; Documented informed consent. Exclusion Criteria: Distant metastasis; Known malignancy diagnosed or require active treatment in the last 5 years, except for cancers that can be cured by surgery including cervical cancer in situ, basal or squamous cell skin cancer, breast ductal carcinoma in situ, localized prostate cancer; Prior thoracic irradiation, chemotherapy, or lobectomy Known diseases or conditions that are contraindicated for radiotherapy or surgery; Allergy to the research medications; Pregnant women or women preparing for pregnancy; Diagnosis of autoimmune disease or history of chronic autoimmune disease Absence of informed consent because of psychological, family, social and other factors; Patients with comorbidities (chronic pulmonary disease, poorly controlled hypertension, unstable angina, myocardial infarction within 6 months, unstable mental disorders requiring therapy).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental arm<br>Two cycles of induction chemotherapy (nab-paclitaxel, 200 mg/m2/day, day1; carboplatin, area under the curve of 5 mg/ml/min, day 1) combined with PD-1 inhibitors （Sintilimab, 200 mg/day, day 1）every 3 weeks followed by concurrent chemoradiotherapy. Patients without progressive disease（PD） will proceed to receive immunotherapy (Sintilimab, 200 mg/day, every 3 weeks) as maintenance treatment for at least 1 year. | Drug: chemotherapy combined with PD-1 inhibitors<br>* Induction chemotherapy combined with PD-1 inhibitors followed with standard concurrent chemoradiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival Rate | Overall survival rate is defined as the percentage of participants who are alive up to 3 years from enrollment | 3 years after last patient enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free Survival (PFS) | Progression-free survival is defined as the time between date of enrollment and first date of recurrence or death, whichever occurs first.Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary tumor site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as PFS events. | 3 years after last patient enrolled | 
| Treatment related complications | complications after treatment | During the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal cancer, chemoradiotherapy, immunotherapy, chemotherapy