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A Phase II Study of CRT Combined With QL1706 in ESCC Patients

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
QL1706
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring Esophageal Cancer, Concurrent chemoradiation, Immunotherapy, CTLA-4, PD-1, QL1706

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects participate voluntarily and sign informed consent.
  2. age:18-75 years, male or female.
  3. Histologically confirmed Advanced Unresectable Esophageal Squamous Cell Carcinomas,unresectable of clinical stage II-IVa patients (include unresectable,or surgical contraindication or refuse surgery)(According to AJCC 8th Edition stage , Pre-treatment clinical stage cT1N2-3M0,cT2-4bN0-3M0.
  4. At least 1 measurable target lesion and/or unmeasurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).

Exclusion Criteria:

  1. Patients who have a history of esophageal cancer surgery.
  2. Previous history of fistula caused by primary tumor infiltration.
  3. a high risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation.
  4. Subjects with poor nutritional status and weight loss of ≥ 10% in the first 2 months of screening have no significant improvement after nursing intervention.
  5. Major surgery or serious trauma within 4 weeks before the first use of the study drug.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    QL1706 plus Chemotherapy and Radiotherapy

    Arm Description

    Radiotherapy: Total 50.4Gy/28 fraction ,1.8Gy per time，5 fractions per week. QL1706 will be administered at a dose of 5 mg/kg intravenously (IV), every 3 weeks, until progressive disease or intolerable or other reasons according to the criteria for termination of treatment). QL1706 will be administered up to 1 year. Chemotherapy: Taxol 135 mg/m2, days 1, 22; Cisplatin 25 mg/m2, day 1-3, day 22-24.

    Outcomes

    Primary Outcome Measures

    PFS assessed by investigators
    Progression-free survival assessed by investigators

    Secondary Outcome Measures

    OS
    Overall survival
    ORR
    Objective Response Rate，Complete Response plus Partial Response
    DoR
    Duration of Response
    The rates and severity of Adverse Events, Serious Adverse Events
    The rates and severity of Adverse Events, Serious Adverse Events

    Full Information

    First Posted
    July 11, 2022
    Last Updated
    August 4, 2022
    Sponsor
    Tianjin Medical University Cancer Institute and Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05490719
    Brief Title
    A Phase II Study of CRT Combined With QL1706 in ESCC Patients
    Official Title
    A Single Arm, Multicenter Phase II Clinical Study of Chemoradiationtherapy Combined With QL1706 (Anti-CTLA-4 and PD-1 Antibody) in Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2022 (Anticipated)
    Primary Completion Date
    January 2024 (Anticipated)
    Study Completion Date
    January 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tianjin Medical University Cancer Institute and Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    This is a single arm, multi-center Phase II Study. This clinical study is an investigator-initiated clinical trial（IIT). The objective of this study is to evaluate the efficacy and safety of Chemoradiationtherapy combined with QL1706 (anti-CTLA-4 and PD-1 antibody) in patients with unresectable locally advanced esophageal squamous cell carcinoma.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophageal Squamous Cell Carcinoma
    Keywords
    Esophageal Cancer, Concurrent chemoradiation, Immunotherapy, CTLA-4, PD-1, QL1706

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    QL1706 plus Chemotherapy and Radiotherapy
    Arm Type
    Experimental
    Arm Description
    Radiotherapy: Total 50.4Gy/28 fraction ,1.8Gy per time，5 fractions per week. QL1706 will be administered at a dose of 5 mg/kg intravenously (IV), every 3 weeks, until progressive disease or intolerable or other reasons according to the criteria for termination of treatment). QL1706 will be administered up to 1 year. Chemotherapy: Taxol 135 mg/m2, days 1, 22; Cisplatin 25 mg/m2, day 1-3, day 22-24.
    Intervention Type
    Drug
    Intervention Name(s)
    QL1706
    Other Intervention Name(s)
    Radiation, Taxol, Cisplatin
    Intervention Description
    QL1706 is a humanized anti-PD1 IgG4 and anti-CTLA-4 IgG4 antibody.
    Primary Outcome Measure Information:
    Title
    PFS assessed by investigators
    Description
    Progression-free survival assessed by investigators
    Time Frame
    Up to approximately 2 years.
    Secondary Outcome Measure Information:
    Title
    OS
    Description
    Overall survival
    Time Frame
    1year and 3years
    Title
    ORR
    Description
    Objective Response Rate，Complete Response plus Partial Response
    Time Frame
    Up to approximately 2 years
    Title
    DoR
    Description
    Duration of Response
    Time Frame
    Up to approximately 2 years
    Title
    The rates and severity of Adverse Events, Serious Adverse Events
    Description
    The rates and severity of Adverse Events, Serious Adverse Events
    Time Frame
    Through study completion, up to approximately 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects participate voluntarily and sign informed consent. age:18-75 years, male or female. Histologically confirmed Advanced Unresectable Esophageal Squamous Cell Carcinomas,unresectable of clinical stage II-IVa patients (include unresectable,or surgical contraindication or refuse surgery)(According to AJCC 8th Edition stage , Pre-treatment clinical stage cT1N2-3M0,cT2-4bN0-3M0. At least 1 measurable target lesion and/or unmeasurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1). Exclusion Criteria: Patients who have a history of esophageal cancer surgery. Previous history of fistula caused by primary tumor infiltration. a high risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation. Subjects with poor nutritional status and weight loss of ≥ 10% in the first 2 months of screening have no significant improvement after nursing intervention. Major surgery or serious trauma within 4 weeks before the first use of the study drug.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qingsong Pang
    Phone
    0086-2223340123-1121
    Email
    pangqingsong2013@163.com

    12. IPD Sharing Statement

    Learn more about this trial

    A Phase II Study of CRT Combined With QL1706 in ESCC Patients

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