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

NCT ID: NCT05833971

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2026-06-01

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.

Conditions

Resectable Esophageal Squamous Cell Carcinoma; Neoadjuvant Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: cadonilimab (AK104) + 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

Group Type: EXPERIMENTAL

cadonilimab+chemotherapy

Intervention Type: DRUG

cadonilimab plus cisplatin and Nab-PTX, Q3W

Interventions

cadonilimab+chemotherapy

cadonilimab plus cisplatin and Nab-PTX, Q3W

Intervention Type: DRUG

Other Intervention Names

AK104

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role: lead

Responsible Party

Jun Liu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Cadonilimab-Neoadjuvant

Identifier Type: -

Identifier Source: org_study_id