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

Guangzhou Institute of Respiratory Disease

Status and phase: Not yet enrolling; Phase 2

Conditions: Resectable Esophageal Squamous Cell Carcinoma; Neoadjuvant Therapy

Treatments: Drug: cadonilimab+chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05833971

Cadonilimab-Neoadjuvant

Details and patient eligibility

About

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.

Enrollment: 43 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Experimental: cadonilimab (AK104) + chemotherapy

Experimental group

Description:

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

Treatment:

Drug: cadonilimab+chemotherapy