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

Shanghai Jiao Tong University

Status and phase: Active, not recruiting; Phase 2

Conditions: Chemotherapy; Esophageal Squamous Cell Carcinomas; Immunotherapy; Concurrent Chemoradiotherapy

Treatments: Drug: chemotherapy combined with PD-1 inhibitors

Study type: Interventional

Funder types: Other

Identifiers

NCT05621707

drjunliu

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

experimental arm

Experimental group

Description:

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.

Treatment:

Drug: chemotherapy combined with PD-1 inhibitors