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

Sponsor
Guangzhou Institute of Respiratory Disease (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05833971
Collaborator
(none)
43
Enrollment
1
Arm
37
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
43 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-arm, Multicenter, Exploratory Study of Cadonilimab in Combination With Chemotherapy for Locally Advaced Esophageal Squamous Cell Carcinoma
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental: cadonilimab (AK104) + chemotherapy

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
cadonilimab plus cisplatin and Nab-PTX, Q3W
Other Names:
  • AK104

    		•

    Outcome Measures

    Primary Outcome Measures

    1. pathologic complete response (pCR) [1 month after resection]

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

    Secondary Outcome Measures

    1. Radical resection (R0) [1 month after resection]

    2. Overall survival(OS) [up to 2 years]

    3. Objective response rate(ORR) [After the start of drugs and before resection]

    4. Disease control rate(DCR) [After the start of drugs and before resection]

    5. Disease-free survival(DFS) [After resection and up to 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Guangzhou Institute of Respiratory Disease

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jun Liu, Professor, Guangzhou Institute of Respiratory Disease
    ClinicalTrials.gov Identifier:
    NCT05833971
    Other Study ID Numbers:
    • Cadonilimab-Neoadjuvant
    First Posted:
    Apr 27, 2023
    Last Update Posted:
    Apr 27, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Squamous Cell
    Esophageal Squamous Cell Carcinoma

    Study Results

    No Results Posted as of Apr 27, 2023