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

A Single-arm, Multicenter, Exploratory Study of Cadonilimab in Combination With Chemotherapy for Locally Advaced Esophageal Squamous Cell Carcinoma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neoadjuvant Therapy; Resectable Esophageal Squamous Cell Carcinoma
• Intervention / Treatment: Drug: cadonilimab+chemotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 43
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: cadonilimab+chemotherapy; cadonilimab plus cisplatin and Nab-PTX, Q3W; Other Names: AK104

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pathologic complete response (pCR)	Analysis of prognosis efficacy of patients: pathologic complete response (pCR)	1 month after resection

Secondary Outcome Measures

Outcome Measure	Time Frame
Radical resection (R0)	1 month after resection
Overall survival(OS)	up to 2 years
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

Collaborators and Investigators

• Sponsor: Guangzhou Institute of Respiratory Disease

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2026

Study Registration Dates

• First Submitted: February 25, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
• Other Study ID Numbers: Cadonilimab-Neoadjuvant

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No