NCT06715501

Efficacy and Safety of Cadonilimab and Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma

Efficacy and Safety of Cadonilimab Combined with Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma-A Single-arm Exploratory Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: First Affiliated Hospital of Ningbo University · Network
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single center, prospective, single arm exploratory clinical trial aimed at evaluating the efficacy and safety of sequential chemoradiotherapy combined with cetuximab in unresectable locally advanced esophageal squamous cell carcinoma. Patients with advanced unresectable esophageal squamous cell carcinoma who meet the criteria, after signing the informed consent form, will first receive induction therapy with cetuximab combined with paclitaxel and carboplatin chemotherapy for 2 cycles. Within 3 weeks after the second dose, RECIST v1.1 will be used for clinical tumor imaging evaluation, and if necessary, gastroscopy biopsy will be performed. Patients without progression will further receive synchronous radiotherapy and chemotherapy. PTV-C accepts 50.4Gy, 28 times; Radiotherapy combined with paclitaxel and carboplatin weekly regimen. Within three months after completion, conduct safety assessments and preliminary evaluations of tumor response every three weeks. Consolidate treatment with cetuximab until 1 year or intolerance or disease progression occurs.

Conditions

• Locally Advanced Esophageal Squamous Cell Carcinoma
• II-IIIB Stages

Interventions

Type	Name	Description
DRUG	Cadonilimab	Cadonilimab is a PD-1/CTLA-4 bispecific antibody. The drug is administered at a fixed dose of 10mg/kg, intravenously (i.v.), on day 1, every 3 weeks (q3w), until disease progression or intolerable toxicity occurs, with a maximum treatment duration of 1 year.
RADIATION	radiotherapy	GTV is defined as visible lesions (GTVp: primary lesion; GTVn: metastatic lymph nodes), CTVp is defined as 3cm above and below the primary lesion, with 0.5cm outward expansion around the periphery, and CTVn is defined as 0.5cm outward expansion of GTVn; PTVp is an outward expansion of 0.5cm for CTVp, and PTVn is an outward expansion of 0.5cm for CTVn. Radiotherapy dose: DT50.4Gy/28f, once daily, 5 times a week
DRUG	carboplatin, paclitaxel	Induction chemotherapy: carboplatin 5AUC，q3w; Paclitaxel 135mg/m2,q3w. Simultaneous chemotherapy: 2AUC/W，total 5w; Paclitaxel 50mg/m2/w，total 5w

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-09-01
• Completion: 2027-09-01
• First posted: 2024-12-04
• Last updated: 2025-03-25

Locations

1 site across 1 country: China