Fruquintinib With PD-1 Inhibitors Versus TAS-102 With Bevacizumab in Late-Line mCRC

Sponsor
Hunan Cancer Hospital
Study ID
NCT06031376
Status
Completed

Conditions

  • Metastatic Colorectal Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Fruquintinib — DRUG
    5mg once daily for 14 days on/7 days off, over a 21-day cycle
  • PD-1 inhibitors — DRUG
    The anti-PD-1 antibody was administered intravenously on day 1, and its recommended dosage was as follows: nivolumab: 240 mg, every 2 weeks; pembrolizumab, camrelizumab, and sintilimab: 200 mg every 3 weeks; and toripalimab: 240 mg every 3 weeks.
  • Trifluridine/Tipiracil — DRUG
    TAS-102 35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days
  • Bevacizumab — DRUG
    Bevacizumab 5 mg /kg, intravenously on days 1,15,every 28 days

Study Details

Fruquintinib with PD-1 inhibitors (FP) and TAS-102 with bevacizumab (TB) are two common therapies for patients with previous-treated metastatic colorectal cancer (mCRC). However, it's still not clear that which therapy can bring better prognosis. Our study sought to investigate the efficacy and safety of fruquintinib with PD-1 Inhibitors versus TAS-102 with bevacizumab in Late-Line mCRC between July 2019 to October 2022July 2019 and June 2021 at the Hunan Cancer Hospital.

Key Dates

First listed
Sep 11, 2023
Start date
Jul 1, 2019
Status verified
Sep 2023
Primary completion
Oct 31, 2022
Completion
Mar 31, 2023

Study Design

Enrollment
106 participants (actual)

Arms

  • Arm: Fruquintinib plus PD-1 inhibitors
    In fruquintinib plus PD-1 inhibitors group,The patients were treated orally with Fruquintinib (5mg once daily for 14 days on/7 days off, over a 21-day cycle), combined with 1 of the 5 anti-PD-1 antibodies (i.e., nivolumab, pembrolizumab, camrelizumab, sintilimab, or toripalimab). The anti-PD-1 antibody was administered intravenously on day 1, and its recommended dosage was as follows: nivolumab: 240 mg, every 2 weeks; pembrolizumab, camrelizumab, and sintilimab: 200 mg every 3 weeks; and toripalimab: 240 mg every 3 weeks.
  • Arm: TAS-102 plus bevacizumab
    In TAS-102 plus BEV group, Patients received TAS-102 (35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days) and bevacizumab (5 mg /kg, intravenously, on days 1 and 15, every 28 days). Bevacizumab was approved to be a 30-minute intravenous infusion before TAS-102.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Approximately 12 months ]

Related Studies