Camrelizumab Combined With Trastuzumab and Chemotherapy in Patients With HER2-positive Advanced Colorectal Cancer

Sponsor
Fudan University
Study ID
NCT05193292
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    200mg, iv, 21d for a treatment cycle
  • Trastuzumab — DRUG
    8 mg/kg loading dose, followed by 6 mg/kg maintenance, iv, 21d for a treatment cycle
  • XELOX regimen — DRUG
    Oxaliplatin, 130 mg/m2, iv, d1; Capecitabine, 1000 mg/m2, po, bid, d1-d14; q3w
  • mFOLFOX6 regimen — DRUG
    Oxaliplatin, 85 mg/m2, iv, d1; Leucovorin, 400 mg/m2, iv, d1; 5-FU, 400mg/m2, iv, d1 followed by 1200 mg/(m2·d)\*2d, civ, 46h; q2w
  • FOLFIRI regimen — DRUG
    Irinotecan, 180 mg/m2, iv, d1; Leucovorin, 400 mg/m2, iv, d1; 5-FU, 400mg/m2, iv, d1 followed by 1200 mg/(m2·d)\*2d, civ, 46h; q2w
  • mXELIRI regimen — DRUG
    Irinotecan, 200 mg/m2, iv, d1; capecitabine, 800 mg/m2, po, bid, d1-d14; q3w
  • mIRIS regimen — DRUG
    Irinotecan, 180 mg/m2, iv, d1; Tiggio Capsules (S-1), 40-60 mg/m2, po, bid, d1-d9; q2w

Study Details

This study aimed to evaluate the efficacy and safety of camrelizumab combined with trastuzumab and chemotherapy in Patients with HER2-positive advanced colorectal cancer

Key Dates

Start date
Jan 31, 2022
Status verified
Dec 2021
Primary completion
Jan 31, 2024
Completion
Jan 31, 2025

Study Design

Enrollment
77 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab combined with trastuzumab and chemotherapy
    Camrelizumab: 200mg, iv, 21d for a treatment cycle Trastuzumab: 8 mg/kg loading dose, followed by 6 mg/kg maintenance, iv, 21d for a treatment cycle Chemotherapy will either be XELOX, mFOLFOX6, FOLFIRI, mXELIRI or mIRIS

Primary Outcome Measure

Objective Response Rate [ Time Frame: [ Time Frame: Approximately 24 months ] ]

Central Contacts

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