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

NCT ID: NCT05621707

Last Updated: 2022-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-20
• Study Completion Date: 2026-11-19

Brief 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.

Conditions

Esophageal Squamous Cell Carcinomas; Concurrent Chemoradiotherapy; Immunotherapy; Chemotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental arm

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.

Group Type: EXPERIMENTAL

chemotherapy combined with PD-1 inhibitors

Intervention Type: DRUG

Induction chemotherapy combined with PD-1 inhibitors followed with standard concurrent chemoradiotherapy

Interventions

chemotherapy combined with PD-1 inhibitors

Induction chemotherapy combined with PD-1 inhibitors followed with standard concurrent chemoradiotherapy

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jun Liu

associate proffessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

drjunliu

Identifier Type: -

Identifier Source: org_study_id