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Camrelizumab Combined With Irinotecan or Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer

Primary Purpose

Second Line Treatment of Gastric Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Camrelizumab
Albumin-Bound Paclitaxel
Irinotecan
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Second Line Treatment of Gastric Cancer

Eligibility Criteria

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

Inclusion Criteria: Age: 18-75 ECOG score: 0 or 1 Unresectable advanced or recurrent gastric cancer/gastroesophageal junction cancer histologically proven adenocarcinoma Received chemotherapy based on platinum and fluorouracil within 12 months Patients not previously treated with paclitaxel or irinotecan Liver function: total bilirubin, ALT and AST<1.5 × ULN (Normal Value upper limit) Renal function: Cr<1.5 × ULN and creatinine clearance ≥ 40 ml/min Echocardiography or radionuclide cardiac function test, LVEF ≥ 50% Expected survival ≥ 3 months Sign the informed consent form Exclusion Criteria: Patients who have received irinotecan or paclitaxel chemotherapy in the past ECOG PS score:>2 Advanced gastric cancer patients with extensive and severe peritoneal metastasis Patients with severe liver and kidney insufficiency or cardiac insufficiency HIV positive, active hepatitis B or C, active pulmonary tuberculosis Patients with active autoimmune diseases, including lupus erythematosus, rheumatoid arthritis, rheumatoid arthritis, etc Patients known to be allergic to any of the study drugs Pregnant or lactating female patients

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    A: Camrelizumab+Albumin-bound paclitaxel

    B: Camrelizumab+Irinotecan

    Arm Description

    Camrelizumab 200mg d1, one cycle every 14 days on the first day; albumin binding paclitaxel: 100 mg/m2, one cycle every 28 days on the first, eighth and fifteenth days

    Camrelizumab 200mg d1, the first day, every 14 days as a cycle Irinotecan: 180 mg/m2, the first day, every 14 days as a cycle

    Outcomes

    Primary Outcome Measures

    Objective Response Rate
    CR+PR

    Secondary Outcome Measures

    Overall Survival
    Time from random start of treatment to death from any cause
    Progression-free Survival
    Time from random start of treatment to death or tumor progression due to any reason
    Treatment related adverse reactions
    Evaluation according to CTC 4.0
    Quality of life assessment
    according to EORTC C30

    Full Information

    First Posted
    November 28, 2022
    Last Updated
    December 20, 2022
    Sponsor
    Zhejiang Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05669807
    Brief Title
    Camrelizumab Combined With Irinotecan or Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer
    Official Title
    A Randomized, Controlled, Multicenter Phase II Study of Camrelizumab Combined With Irinotecan or Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2022 (Anticipated)
    Primary Completion Date
    November 2023 (Anticipated)
    Study Completion Date
    November 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zhejiang Cancer Hospital

    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 study is a multicenter, open, and randomized clinical phase II exploratory study. The "pick the winner" study design is used to determine and select which chemotherapy drug (irinotecan vs. albumin plus paclitaxel) is more effective in the second-line treatment of advanced gastric cancer, and it is more hopeful to carry out the follow-up phase III study in the second-line treatment of advanced gastric cancer (karelizumab+chemotherapy vs. chemotherapy). The study plans to include 184 patients with advanced gastric cancer who have received first-line platinum+fluorouracil progression, randomly use albumin paclitaxel+carrelizumab or irinotecan+carrelizumab second-line therapy, and observe the objective effective rate (ORR), total survival time (OS), progression free survival time (PFS), treatment related adverse reactions, quality of life and other clinical indicators after receiving the above treatment, Then determine the second line scheme which is more advantageous.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Second Line Treatment of Gastric Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    184 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    A: Camrelizumab+Albumin-bound paclitaxel
    Arm Type
    Experimental
    Arm Description
    Camrelizumab 200mg d1, one cycle every 14 days on the first day; albumin binding paclitaxel: 100 mg/m2, one cycle every 28 days on the first, eighth and fifteenth days
    Arm Title
    B: Camrelizumab+Irinotecan
    Arm Type
    Experimental
    Arm Description
    Camrelizumab 200mg d1, the first day, every 14 days as a cycle Irinotecan: 180 mg/m2, the first day, every 14 days as a cycle
    Intervention Type
    Drug
    Intervention Name(s)
    Camrelizumab
    Other Intervention Name(s)
    Camrel
    Intervention Description
    200mg d1, the first day, every 14 days as a cycle
    Intervention Type
    Drug
    Intervention Name(s)
    Albumin-Bound Paclitaxel
    Other Intervention Name(s)
    ABP
    Intervention Description
    100 mg/m2, the 1st, 8th and 15th days, every 28 days as a cycle
    Intervention Type
    Drug
    Intervention Name(s)
    Irinotecan
    Other Intervention Name(s)
    Iri
    Intervention Description
    180 mg/m2, the first day, every 14 days as a cycle
    Primary Outcome Measure Information:
    Title
    Objective Response Rate
    Description
    CR+PR
    Time Frame
    up to 12 weeks
    Secondary Outcome Measure Information:
    Title
    Overall Survival
    Description
    Time from random start of treatment to death from any cause
    Time Frame
    From date of randomization until the date of date of death from any cause, assessed up to 24 months
    Title
    Progression-free Survival
    Description
    Time from random start of treatment to death or tumor progression due to any reason
    Time Frame
    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
    Title
    Treatment related adverse reactions
    Description
    Evaluation according to CTC 4.0
    Time Frame
    24 months
    Title
    Quality of life assessment
    Description
    according to EORTC C30
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age: 18-75 ECOG score: 0 or 1 Unresectable advanced or recurrent gastric cancer/gastroesophageal junction cancer histologically proven adenocarcinoma Received chemotherapy based on platinum and fluorouracil within 12 months Patients not previously treated with paclitaxel or irinotecan Liver function: total bilirubin, ALT and AST<1.5 × ULN (Normal Value upper limit) Renal function: Cr<1.5 × ULN and creatinine clearance ≥ 40 ml/min Echocardiography or radionuclide cardiac function test, LVEF ≥ 50% Expected survival ≥ 3 months Sign the informed consent form Exclusion Criteria: Patients who have received irinotecan or paclitaxel chemotherapy in the past ECOG PS score:>2 Advanced gastric cancer patients with extensive and severe peritoneal metastasis Patients with severe liver and kidney insufficiency or cardiac insufficiency HIV positive, active hepatitis B or C, active pulmonary tuberculosis Patients with active autoimmune diseases, including lupus erythematosus, rheumatoid arthritis, rheumatoid arthritis, etc Patients known to be allergic to any of the study drugs Pregnant or lactating female patients
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ji Zhu
    Phone
    0571-88128142
    Email
    leo.zhu@126.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jinwen Shen
    Phone
    0571-88128142
    Email
    shenjw2005@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ji Zhu
    Organizational Affiliation
    Zhejiang Cancer Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Camrelizumab Combined With Irinotecan or Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer

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