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/AClinical Study ID
NCT05833971
Cadonilimab-Neoadjuvant
Ages 18-70 All Genders
Study Summary
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