Raltitrexed-based Chemotherapy Plus Bevacizumab in Retreated Patients With Advanced Colorectal Cancer

Sponsor
Jiangsu Cancer Institute & Hospital
Study ID
NCT03126071
Phase
PHASE2
Status
Unknown

Conditions

  • Advanced Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Raltitrexed — DRUG
    Raltitrexed:3mg/m2,iv 15min,d1,q3w.
  • Irinotecan — DRUG
    Irinotecan:250mg/m2,iv 90min,d1,q3w.
  • Oxaliplatin — DRUG
    Oxaliplatin:130mg/m2,iv 120min,d1,q3w.
  • Bevacizumab — DRUG
    Bevacizumab:75mg/kg,iv 30min,d1,q3w.

Study Details

The objective is to investigate the efficacy and safety of raltitrexed-based chemotherapy plus bevacizumab in the treatment of advanced colorectal cancer

Key Dates

Start date
Feb 15, 2017
Status verified
Aug 2021
Primary completion
Aug 15, 2022
Completion
Feb 15, 2023

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Raltitrexed and Irinotecan（RALIRI） plus Bevacizumab(AVASTIN)
    Irinotecan:250mg/m2 iv,90min,d1, Raltitrexed:3.0mg/m2,iv,15min,d1, Bevacizumab:7.5mg/kg iv,30min,d1,q3w. Maintenance: Raltitrexed(3.0mg/m2,iv,15min,d1,q3w)+Bevacizumab(7.5 mg/kg q3w)
  • Experimental: Raltitrexed and Oxaliplatin（RALOX） plus Bevacizumab(AVASTIN)
    Oxaliplatin:130mg/m2 iv,120min,d1, Raltitrexed:3.0mg/m2,iv,15min,d1, Bevacizumab:7.5mg/kg iv,30min,d1,q3w. Maintenance: Raltitrexed(3.0mg/m2,iv,15min,d1,q3w)+Bevacizumab(7.5 mg/kg q3w)

Primary Outcome Measure

PFS [ Time Frame: 6 months ]

Central Contacts

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