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

Neoadjuvant Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05833971
• Other study ID #: Cadonilimab-Neoadjuvant
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2023
• Est. completion date: June 1, 2026

Study information

• Verified date: April 2023
• Source: Guangzhou Institute of Respiratory Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 43
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma
• Neoadjuvant Therapy
• Resectable Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• cadonilimab+chemotherapy
cadonilimab plus cisplatin and Nab-PTX, Q3W

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathologic complete response (pCR)	Analysis of prognosis efficacy of patients: pathologic complete response (pCR)	1 month after resection
Secondary	Radical resection (R0)		1 month after resection
Secondary	Overall survival(OS)		up to 2 years
Secondary	Objective response rate(ORR)		After the start of drugs and before resection
Secondary	Disease control rate(DCR)		After the start of drugs and before resection
Secondary	Disease-free survival(DFS)		After resection and up to 2 years