Toripalimab Plus Bevacizumab and Chemotherapy as Neoadjuvant Therapy in Advanced MSI-H or dMMR Colorectal Cancer

Sponsor
Peking University
Study ID
NCT04988191
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Toripalimab — DRUG
    Neoadjuvant therapy: Toripalimab is given by intravenous infusion at 3mg/kg d1 every 2 weeks for 3 cycles. Adjuvant therapy: Toripalimab is given by intravenous infusion at a dose of 240mg every 3 weeks for up to 9 cycles.
  • Bevacizumab — DRUG
    Neoadjuvant therapy: Bevacizumab is given by intravenous infusion at 5mg/kg d1 every 2 weeks for 3 cycles.
  • Irinotecan — DRUG
    Neoadjuvant therapy: Irinotecan is given by intravenous infusion at 180mg/m2 d1 every 2 weeks for 2 cycles.

Study Details

This is a trial investigating the efficacy and safety of Toripalimab combined with bevacizumab and chemotherapy as neoadjuvant therapy in patients with advanced microsatellite instability-high (MSI-H) or DNA mismatch repair-deficient (dMMR) colorectal cancer.

Key Dates

Start date
Dec 24, 2020
Status verified
Jul 2021
Primary completion
Jun 24, 2023
Completion
Dec 24, 2023

Study Design

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

Arms

  • Experimental: Toripalimab combined with bevacizumab and chemotherapy

Primary Outcome Measure

Pathological complete response rate based on blinded, independent, central review [ Time Frame: 10 weeks ]

Central Contacts

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