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Trifluridine/Tipiracil Combined With Oxaliplatin and Bevacizumab Versus XELOX Plus Bevacizumab in mCRC

NCT05077839 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2021-10-25

No results posted yet for this study

Summary

This is a two-group, parallel, randomized, standard-control phase II study comparing the safety and efficacy of trifluridine/tipiracil combined with oxaliplatin and bevacizumab versus XELOX plus bevacizumab in the first-line treatment of advanced colorectal cancer. This study was conducted in the Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Institute and Hospital.

Patients with advanced colorectal cancer will be randomly assigned (1:1) to trifluridine/tipiracil combined with oxaliplatin and bevacizumab (experimental group) or XELOX plus bevacizumab (control group) after signing informed consent. In this study, 184 patients will be enrolled, 92 patients will receive trifluridine/tipiracil combined with oxaliplatin and bevacizumab and 92 patients will receive standard therapy.

In the experimental group, the treatment regimen is trifluridine/tipiracil 35mg/m2 orally taken on d1-5 and d8-12, oxaliplatin 85mg/m2 and bevacizumab 5mg/kg intravenously infused on d1 and d15 every 4 weeks, up to 6 cycles. Then patients will be given trifluridine/tipiracil and bevacizumab maintenance treatment. Patients enrolled in this group could acquire trifluridine/tipiracil free of charge.

The control group was XELOX plus bevacizumab regimen, bevacizumab 7.5mg/kg, d1 oxaliplatin 130mg/m2, d1, capecitabine 1000mg/m2, orally, bid (half an hour after breakfast and dinner), d1-14, every 3 weeks, up to 8 cycles. Then patients will be given capecitabine and bevacizumab maintenance treatment.

Patients received regular and periodic reviews, with imaging evaluations every 8 weeks. Safety will be evaluated by AE and laboratory tests. All patients were followed up every 3 months until death according to the plan.

Conditions

  • First-line Treatment
  • Advanced Colorectal Cancer

Interventions

DRUG

Trifluridine/Tipiracil

Trifluridine/tipiracil was approved in the third-line treatment of advanced colorectal cancer. Its efficacy in the first-line treatment was unknown.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Principal Investigators

  • Yi Ba, MD · Tianjin Medical University Cancer Institute and Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2024-08-31
Completion
2025-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05077839 on ClinicalTrials.gov