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

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

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.

Inclusion Criteria:

1. Aged ≥ 18 years at the time of screening.
2. Histologically confirmed squamous cell carcinoma;
3. Locally-advanced ,medical inoperability, technical irresectability, or patient refusal to surgery;
4. Eastern Cooperative Oncology Group (ECOG) performance status:0-2;
5. Able to eat a semi-liquid diet;
6. Less than 20% weight loss within 6 months;
7. Adequate hepatic function, renal function, hematologic function and coagulation function;
8. Documented informed consent.

Exclusion Criteria:

1. Distant metastasis;
2. 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;
3. Prior thoracic irradiation, chemotherapy, or lobectomy
4. Known diseases or conditions that are contraindicated for radiotherapy or surgery;
5. Allergy to the research medications;
6. Pregnant women or women preparing for pregnancy;
7. Diagnosis of autoimmune disease or history of chronic autoimmune disease
8. Absence of informed consent because of psychological, family, social and other factors;
9. Patients with comorbidities (chronic pulmonary disease, poorly controlled hypertension, unstable angina, myocardial infarction within 6 months, unstable mental disorders requiring therapy).