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

Last updated: April 18, 2023
Sponsor: Guangzhou Institute of Respiratory Disease
Overall Status: Active - Not Recruiting

Phase

2

Condition

Carcinoma

Lung Cancer

Esophageal Cancer

Treatment

N/A

Clinical Study ID

NCT05833971
Cadonilimab-Neoadjuvant
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18-70 years, both men and women
  • Pathologically confirmed esophageal squamous cell carcinoma,and the clinic staging iscT2N1-3M0 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 measurablelesions 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 serumpregnancy test within 7 days before receiving the first study drug administration.Male and female patients need to use high-efficiency contraception during treatmentuntil at least 8 weeks after stop the treatment
  • Sign the informed consent form before any trial-related procedures are implemented

Exclusion

Exclusion Criteria:

  • -Other malignancies diagnosed within 5 years prior to the first administration of thestudy drug, except effectively treated basal cell carcinoma of the skin, squamous cellcarcinoma of the skin, and/or effectively resected in situ cervical and/or breastcancer
  • 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

Total Participants: 43
Study Start date:
May 01, 2023
Estimated Completion Date:
June 01, 2026