Neoadjuvant Therapy, Resectable Esophageal Squamous Cell Carcinoma
Conditions
Brief 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.
Interventions
DRUGcadonilimab+chemotherapy
cadonilimab plus cisplatin and Nab-PTX, Q3W
Sponsors
Guangzhou Institute of Respiratory Disease
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pathologic complete response (pCR) | 1 month after resection | Analysis of prognosis efficacy of patients: pathologic complete response (pCR) |
Secondary
| 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 |
Outcome results
None listed