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

Sponsor
Zhejiang Cancer Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05669807
Collaborator
(none)
184
Enrollment
2
Arms
35
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
184 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: A: Camrelizumab+Albumin-bound paclitaxel

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

Drug: Camrelizumab
200mg d1, the first day, every 14 days as a cycle
Other Names:
  • Camrel

    • Drug: Albumin-Bound Paclitaxel
    100 mg/m2, the 1st, 8th and 15th days, every 28 days as a cycle
    Other Names:
  • ABP

    		•
    Experimental: B: Camrelizumab+Irinotecan

    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

    Drug: Camrelizumab
    200mg d1, the first day, every 14 days as a cycle
    Other Names:
  • Camrel

    • Drug: Irinotecan
    180 mg/m2, the first day, every 14 days as a cycle
    Other Names:
  • Iri

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate [up to 12 weeks]

      CR+PR

    Secondary Outcome Measures

    1. Overall Survival [From date of randomization until the date of date of death from any cause, assessed up to 24 months]

      Time from random start of treatment to death from any cause

    2. Progression-free Survival [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]

      Time from random start of treatment to death or tumor progression due to any reason

    3. Treatment related adverse reactions [24 months]

      Evaluation according to CTC 4.0

    4. Quality of life assessment [24 months]

      according to EORTC C30

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Zhejiang Cancer Hospital

    Investigators

    • Principal Investigator: Ji Zhu, Zhejiang Cancer Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ji Zhu, MD, Zhejiang Cancer Hospital
    ClinicalTrials.gov Identifier:
    NCT05669807
    Other Study ID Numbers:
    • CARTOnG-2101
    First Posted:
    Jan 3, 2023
    Last Update Posted:
    Jan 3, 2023
    Last Verified:
    Dec 1, 2022
    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:
    Stomach Neoplasms
    Paclitaxel
    Irinotecan
    Albumin-Bound Paclitaxel

    Study Results

    No Results Posted as of Jan 3, 2023