Pemetrexed and TAS-102 in Combination With Bevacizumab in Refractory Colorectal Cancer

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT04683965
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Pemetrexed — DRUG
    Pemetrexed 500 mg/m2 d1
  • TAS-102 — DRUG
    TAS-102, capsule, 35mg/m2, bid,p.o, d1\~5,d8\~12
  • Bevacizumab — DRUG
    Bevacizumab 5 mg/kg d1,d14

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. TAS-102 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
Dec 24, 2020
Start date
Jan 1, 2021
Status verified
Jul 2022
Primary completion
Jan 1, 2024
Completion
May 1, 2024

Study Design

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

Arms

  • Experimental: Pemetrexed + TAS-102 + Bevacizumab
    Pemetrexed 500 mg/m2 d1+ TAS-102, capsule, 35mg/m2, bid,po, d1\~5, d8\~12 + Bevacizumab 5 mg/kg d1, d14; Repeated every 4 weeks

Primary Outcome Measure

Objective response rate(ORR) [ 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 ]

Related Studies