Overview

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

Status:
Not yet recruiting
Trial end date:
2026-11-19
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai Chest Hospital
Treatments:
Immune Checkpoint Inhibitors
Criteria
Inclusion Criteria:

1. Age:18-75 years of age;

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).