Cadonilimab in Combination With Chemotherapy for Locally Advaced Esophageal Squamous Cell Carcinoma

Phase 2

Not yet recruiting

• Conditions: Resectable Esophageal Squamous Cell Carcinoma; Neoadjuvant Therapy
• Interventions: Drug: cadonilimab+chemotherapy

• Registration Number: NCT05833971
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

Brief Summary

This is a single-arm, multicenter, exploratory study to evaluate the efficacy and safety of AK104 in combination with cisplatin and paclitaxel in the treatment of resectable locally advanced esophageal squamous carcinoma.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-25
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-18
• Last Update Submitted: 2023-04-18
• Study First Posted: 2023-04-27
• Last Update Posted: 2023-04-27
• Study Start: 2023-05-01
• Primary Completion: 2024-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Age 18-70 years, both men and women
• Pathologically confirmed esophageal squamous cell carcinoma，and the clinic staging is cT2N1-3M0 or cT3N0-3M0 or cT4N0-3M0, TNM staging is II-IVA
• Non-cervical esophageal carcinoma
• Patients who have never received systemic antitumor therapy and who have measurable lesions that meet RECIST 1.1 criteria
• ECOG score 0-1
• Life expectancy ≥12 months
• Patients with normal function organs, no serious abnormalities of blood, heart, lung, liver, kidney function, and immunodeficiency disease
• For female subjects of childbearing age, they should have a negative urine or serum pregnancy test within 7 days before receiving the first study drug administration. Male and female patients need to use high-efficiency contraception during treatment until at least 8 weeks after stop the treatment
• Sign the informed consent form before any trial-related procedures are implemented

Exclusion Criteria

• -Other malignancies diagnosed within 5 years prior to the first administration of the study drug, except effectively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or effectively resected in situ cervical and/or breast cancer
• ulcerative esophageal squamous cell carcinoma
• Esophageal or tracheal fistula
• History of allergy to study drug components
• History of immune disease
• Patients with any serious or uncontrolled systemic disease
• The presence of any adverse event (CTCAE>grade 1) caused by prior therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: cadonilimab (AK104) + chemotherapy	cadonilimab+chemotherapy	Drug: Cadonilimab+ chemotherapy，10mg/kg IV every 3 weeks (Q3W)，Other Name: AK104； Cisplatin，60-75mg/m2 IV every 3 weeks (Q3W)，Other Name: DDP；Albumin Paclitaxel，260mg/m2 IV every 3 weeks D1, 8(Q3W)，Other Name: Nab-PTX

Primary Outcome Measures

Name	Time	Method
pathologic complete response (pCR)	1 month after resection	Analysis of prognosis efficacy of patients: pathologic complete response (pCR)

Secondary Outcome Measures

Name	Time	Method
Objective response rate(ORR)	After the start of drugs and before resection
Disease control rate(DCR)	After the start of drugs and before resection
Disease-free survival(DFS)	After resection and up to 2 years
Radical resection (R0)	1 month after resection
Overall survival(OS)	up to 2 years