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Trial Title:
Cadonilimab in Combination With Chemotherapy for Locally Advaced Esophageal Squamous Cell Carcinoma
NCT ID:
NCT05833971
Condition:
Resectable Esophageal Squamous Cell Carcinoma
Neoadjuvant Therapy
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
cadonilimab+chemotherapy
Description:
cadonilimab plus cisplatin and Nab-PTX, Q3W
Arm group label:
Experimental: cadonilimab (AK104) + chemotherapy
Other name:
AK104
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
May 1, 2023
Completion date:
June 1, 2026
Lead sponsor:
Agency:
Guangzhou Institute of Respiratory Disease
Agency class:
Other
Source:
Guangzhou Institute of Respiratory Disease
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05833971
