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RECRUITING
NCT07751055
PHASE2

Neoadjuvant Chemoradiotherapy Combined With CTLA-4 Monoclonal Antibody Plus PD-1 Monoclonal Antibody for Locally Advanced Esophageal Cancer

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This is a prospective, single-arm phase II clinical trial intended to investigate the efficacy of neoadjuvant CTLA-4 monoclonal antibody combined with PD-1 monoclonal antibody plus preoperative chemoradiotherapy for locally advanced esophageal cancer. A total of 44 patients with resectable esophageal squamous cell carcinoma (ESCC) will be enrolled.All enrolled subjects will receive induction therapy with the combination of a CTLA-4 inhibitor and a PD-1 inhibitor. Three weeks afterwards, patients will transition to concurrent chemoradiotherapy combined with PD-1 inhibitor. Intensity-modulated radiotherapy (IMRT) will be delivered at a total dose of 40 Gy in 20 fractions. Radical esophagectomy with two-field thoracic and abdominal lymph node dissection will be performed 6-8 weeks after completion of chemoradiotherapy.The primary objective of this trial is to evaluate the efficacy and safety of the triplet regimen consisting of CTLA-4 inhibitor plus PD-1 inhibitor combined with preoperative chemoradiotherapy in locally advanced esophageal cancer, so as to further optimize the multimodal therapeutic strategy for esophageal cancer.

Official title: A Prospective, Single-Arm Phase II Clinical Study of Neoadjuvant Chemoradiotherapy Combined With CTLA-4 Monoclonal Antibody Plus PD-1 Monoclonal Antibody for Locally Advanced Esophageal Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

51

Start Date

2026-08-01

Completion Date

2030-12-31

Last Updated

2026-08-07

Healthy Volunteers

No

Interventions

DRUG

Ipilimumab (1mg/kg)

Chemotherapy and dual immunotherapy agents Anti-CTLA-4 monoclonal antibody (IBI310): 1 mg/kg via intravenous infusion on Day 1 (D1);

DRUG

Sinitilimab

Sintilimab (anti-PD-1 monoclonal antibody) will be administered at a dose of 200 mg via intravenous infusion on Day 1, Day 22 and Day 43.

DRUG

Nab-paclitaxel + Cisplatin

Nab-paclitaxel: 75 mg/m² via intravenous infusion on D22, D29, D36 and D43; Cisplatin: 25 mg/m² via intravenous infusion on D22, D29, D36 and D43.

RADIATION

IMRT combine with cisplatin concurrent chemotherapy

Intensity-modulated radiotherapy (IMRT) will be adopted with a total dose of 40 Gy in 20 fractions. Radiotherapy starts on Day 22, administered 5 times per week and completed within 4 weeks.

Locations (1)

No.651 Dongfeng East Road,Guangzhou

Guangzhou, Guangdong, China