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

Study Overview
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Brief Summary
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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.

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

Conditions
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Resectable Esophageal Squamous Cell Carcinoma, Neoadjuvant Therapy

Intervention / Treatment
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* Drug: cadonilimab+chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: cadonilimab (AK104) + chemotherapy<br>Drug: Cadonilimab+ chemotherapy，10mg/kg IV every 3 weeks (Q3W)，Other Name: AK104； Cisplatin，60-75mg/m2 IV every 3 weeks (Q3W)，Other Name: DDP；Albumin Paclitaxel，260mg/m2 IV every 3 weeks D1, 8(Q3W)，Other Name: Nab-PTX | Drug: cadonilimab+chemotherapy<br>* cadonilimab plus cisplatin and Nab-PTX, Q3W<br>* Other names: AK104;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathologic complete response (pCR) | Analysis of prognosis efficacy of patients: pathologic complete response (pCR) | 1 month after resection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |