Pemetrexed and S-1 in Combination With Bevacizumab in Refractory Colorectal Cancer

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT03843853
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Pemetrexed — DRUG
    Pemetrexed 500 mg/m2 d1
  • S-1 — DRUG
    S-1 (20mg、25mg), capsule, 40\~60mg, Bid,p.o, d1\~14
  • Bevacizumab — DRUG
    Bevacizumab 7.5 mg/kg d1

Study Details

Limited agents are optional after standard first and second line treatment for mCRC. Only Regorafenib and Fruquintinib are approved in China. PFS of these targeted drugs are not very long. Pemetrexed has shown significant efficacy in advanced lung cancer regarding PFS and OS with controllable toxicity. S-1 has been used in colorectal cancer with promising outcomes. Bevacizumab is also an important monoclonal antibody which could make benefits in treated patients. This study is aimed to explore the efficacy, safety in advanced colorectal cancer failed to standard therapy in Chinese population.

Key Dates

First listed
Feb 18, 2019
Start date
May 1, 2019
Status verified
Jul 2022
Primary completion
Nov 1, 2021
Completion
May 1, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pemetrexed + S-1 + Bevacizumab
    Pemetrexed 500 mg/m2 d1+ S-1 (20mg、25mg), capsule, 40\~60mg, Bid,p.o, d1\~14 + Bevacizumab 7.5 mg/kg d1; Repeated every 3 weeks

Primary Outcome Measure

Progression-free Survival(PFS) [ Time Frame: From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before November 1,2021 ]

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