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ACTIVE NOT RECRUITING
NCT06143748
PHASE2

Combination of Cadonilimab and Chemoradiotherapy in Esophageal Cancer (EC-CRT-006)

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

Definitive chemoradiotherapy (CRT) is the standard treatment option for unresectable locally advanced esophageal cancer. However, as high as more than 40% of patients with esophageal cancer experienced locoregional recurrence after definitive CRT. Immune checkpoint inhibitors targeting PD-1/PD-L1 and/or CTLA-4 have shown substantial clinical benefits in advanced esophageal cancer. Recently, the combination of immunotherapy with CRT has emerged as a promising strategy to improve clinical outcomes in esophageal cancer. The aim of this study was to evaluate the efficacy and safety of cadonilimab (a bispecific PD-1/CTLA-4 antibody) combined with induction chemotherapy followed by definitive radiotherapy in patients with locally advanced esophageal squamous cell carcinoma.

Official title: Cadonilimab Combined With Induction Chemotherapy and Definitive Radiotherapy for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma: a Phase II, Single-arm Trial (EC-CRT-006)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2024-03-02

Completion Date

2027-12-31

Last Updated

2025-09-17

Healthy Volunteers

No

Interventions

DRUG

Cadonilimab

Patients received cadonilimab 10 mg/kg every 3 weeks for up to 16 cycles.

DRUG

Paclitaxel and cisplatin

Patients received 2 cycles of induction chemotherapy with paclitaxel/cisplatin (paclitaxel 135 mg/m2 and cisplatin 75 mg/m2) prior to radiotherapy. Then patients will not receive chemotherapy during radiotherapy.

RADIATION

intensity-modulated radiotherapy

All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is 50.4 Gy in 28 fractions over 5-6 weeks.

Locations (1)

Sun Yat-sen University

Guangzhou, Guangdong, China