SALIRI Based Regimen as First-line Treatment for Advanced Metastatic Colorectal Cancer

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT05160896
Phase
PHASE2
Status
Unknown

Conditions

  • Advanced Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Raltitrexed — DRUG
    Raltitrexed 2 mg/m² iv, 15min. day 1
  • Irinotecan — DRUG
    Irinotecan 180 mg/m² iv, 30 - 90 min. day 1
  • Bevacizumab — DRUG
    Bevacizumab 5 mg/kg, iv, day 1
  • Cetuximab — DRUG
    cetuximab 500 mg/ m² , iv, day 1

Study Details

The objective is to investigate the efficacy and safety of raltitrexed combined with Irinotecan (SALIRI) based regimen as first-line treatment for advanced metastatic colorectal cancer(mCRC).

Key Dates

Start date
Nov 12, 2021
Status verified
Jun 2023
Primary completion
Jun 30, 2023
Completion
Jun 30, 2023

Study Design

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

Arms

  • Experimental: MSS or MSI-L/pMMR, RAS and BRAF are both wild type
    the primary lesion is located in the left colorectal: SALIRI plus cetuximab One cycle (cycle duration 14 days) consists of: Raltitrexed 2 mg/m² iv, 15min. day 1 Irinotecan 180 mg/m² iv, 30 - 90 min. day 1 cetuximab 500 mg/ m² , iv, day 1 the primary lesion is located in the right colorectal: SALIRI plus bevacizumab One cycle (cycle duration 14 days) consists of: Raltitrexed 2 mg/m² iv, 15min. day 1 Irinotecan 180 mg/m² iv, 30 - 90 min. day 1 Bevacizumab 5 mg/kg, iv, day 1

Primary Outcome Measure

ORR [ Time Frame: 24 months ]

Central Contacts