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

NCT05621707 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: drjunliu
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Immunotherapy; Esophageal Squamous Cell Carcinomas; Concurrent Chemoradiotherapy; Chemotherapy

Keywords

esophageal cancer; chemoradiotherapy; immunotherapy; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Overall Survival Rate

  Overall survival rate is defined as the percentage of participants who are alive up to 2 years from enrollment

  2 years after last patient enrolled

Secondary Outcomes (2)

• progression-free Survival (PFS)

  2 years after last patient enrolled

• Treatment related complications

  During the procedure

Study Arms (1)

experimental arm

EXPERIMENTAL

Induction Therapy: Two cycles of induction chemotherapy (nab-paclitaxel 200 mg/m², day 1; carboplatin AUC 5, day 1) combined with a PD-1 inhibitor (200 mg, day 1) every 3 weeks. Concurrent Therapy: Followed by concurrent chemoradiotherapy (CCRT). Maintenance Therapy: Patients without progressive disease (PD) will receive maintenance immunotherapy with a PD-1 inhibitor (200 mg every 3 weeks) for up to 1 year.

Drug: chemotherapy combined with PD-1 inhibitors

Interventions

chemotherapy combined with PD-1 inhibitors DRUG

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

experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 18 years at the time of screening.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: November 5, 2022
• First Posted: November 18, 2022
• Study Start: November 2, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

CN (1)