Study of Chemotherapy Combination With Autologous Cell Immunotherapy in the Recurrent and Metastatic Colorectal Cancer

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT03950154
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab Injection [Avastin] — DRUG
    Bevacizumab injection
  • Oxaliplatin — DRUG
    Oxaliplatin injection
  • Capecitabine — DRUG
    Capecitabine oral agent
  • PD1-T cells — BIOLOGICAL
    PD1-T cells injection

Study Details

This study evaluates the effect and safty of PD-1 monoclonal antibody-activated autologous peripheral blood lymphocyte (PD1-T) combined with XELOX and bevacizumab in the first-line treatment of recurrent and metastatic colorectal cancer. Half of participants receive PD1-T combined with XELOX and bevacizumab, while the other half will receive XELOX and bevacizumab.

Key Dates

First listed
May 15, 2019
Start date
Jun 1, 2019
Status verified
Jul 2023
Primary completion
Aug 1, 2023
Completion
Aug 1, 2023

Study Design

Enrollment
198 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Bevacizumab \& Oxaliplatin \& Capecitabine \& PD1-T cells Bevacizumab, 7.5mg/kg, intravenous infusion, d1; Oxaliplatin, 130mg/m2, intravenous infusion, d1; Capecitabine, 1g/m2, oral administration, d1-14; PD1-T cells, 1x10\^10 (10 billion), intravenous infusion, d17; Q3W, 6 cycles. After 6 cycles, Bevacizumab, 7.5mg/kg, intravenous infusion, d1; Capecitabine, 1g/m2, oral administration, d1-14; Q3W, maintenance treatment.
  • Active Comparator: Arm 2: Control
    Bevacizumab \& Oxaliplatin \& Capecitabine Bevacizumab, 7.5mg/kg, intravenous infusion, d1; Oxaliplatin, 130mg/m2, intravenous infusion, d1; Capecitabine, 1g/m2, oral administration, d1-14; Q3W, 6 cycles. After 6 cycles, Bevacizumab, 7.5mg/kg, intravenous infusion, d1; Capecitabine, 1g/m2, oral administration, d1-14; Q3W, maintenance treatment.

Primary Outcome Measure

Progression-free survival [ Time Frame: 3 years ]

Central Contacts

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