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

Phase 2

Not yet recruiting

• Conditions: Esophageal Squamous Cell Carcinomas; Concurrent Chemoradiotherapy; Immunotherapy; Chemotherapy
• Interventions: Drug: chemotherapy combined with PD-1 inhibitors

• Registration Number: NCT05621707
• Lead Sponsor: Shanghai Chest Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-05
• Study First Submitted QC: 2022-11-17
• Last Update Submitted: 2022-11-17
• Study First Posted: 2022-11-18
• Last Update Posted: 2022-11-18
• Study Start: 2022-11-20
• Primary Completion: 2024-11-19
• Study Completion: 2026-11-19

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental arm	chemotherapy combined with PD-1 inhibitors	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.

Primary Outcome Measures

Name	Time	Method
Overall Survival Rate	3 years after last patient enrolled	Overall survival rate is defined as the percentage of participants who are alive up to 3 years from enrollment

Secondary Outcome Measures

Name	Time	Method
Treatment related complications	During the procedure	complications after treatment
progression-free Survival (PFS)	3 years after last patient enrolled	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.