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

NAEnrolling by invitationINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

December 1, 2024

Primary Completion Date

September 1, 2025

Study Completion Date

September 1, 2027

Conditions
Locally Advanced Esophageal Squamous Cell CarcinomaII-IIIB Stages
Interventions
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

Trial Locations (1)

315001

First Affiliated Hospital of Ningbo University, Ningbo

All Listed Sponsors
lead

First Affiliated Hospital of Ningbo University

NETWORK