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

Primary Purpose

Resectable Esophageal Squamous Cell Carcinoma, Neoadjuvant Therapy

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
cadonilimab+chemotherapy
Sponsored by
Guangzhou Institute of Respiratory Disease
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Resectable Esophageal Squamous Cell Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Experimental: cadonilimab (AK104) + chemotherapy

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    pathologic complete response (pCR)
    Analysis of prognosis efficacy of patients: pathologic complete response (pCR)

    Secondary Outcome Measures

    Radical resection (R0)
    Overall survival(OS)
    Objective response rate(ORR)
    Disease control rate(DCR)
    Disease-free survival(DFS)

    Full Information

    First Posted
    February 25, 2023
    Last Updated
    April 18, 2023
    Sponsor
    Guangzhou Institute of Respiratory Disease
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05833971
    Brief Title
    Cadonilimab in Combination With Chemotherapy for Locally Advaced Esophageal Squamous Cell Carcinoma
    Official Title
    A Single-arm, Multicenter, Exploratory Study of Cadonilimab in Combination With Chemotherapy for Locally Advaced Esophageal Squamous Cell Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    June 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Guangzhou Institute of Respiratory Disease

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Resectable Esophageal Squamous Cell Carcinoma, Neoadjuvant Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    43 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental: cadonilimab (AK104) + chemotherapy
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    cadonilimab+chemotherapy
    Other Intervention Name(s)
    AK104
    Intervention Description
    cadonilimab plus cisplatin and Nab-PTX, Q3W
    Primary Outcome Measure Information:
    Title
    pathologic complete response (pCR)
    Description
    Analysis of prognosis efficacy of patients: pathologic complete response (pCR)
    Time Frame
    1 month after resection
    Secondary Outcome Measure Information:
    Title
    Radical resection (R0)
    Time Frame
    1 month after resection
    Title
    Overall survival(OS)
    Time Frame
    up to 2 years
    Title
    Objective response rate(ORR)
    Time Frame
    After the start of drugs and before resection
    Title
    Disease control rate(DCR)
    Time Frame
    After the start of drugs and before resection
    Title
    Disease-free survival(DFS)
    Time Frame
    After resection and up to 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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