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Alternating Treatment With Fruquintinib and Bevacizumab Plus Capecitabine as Maintenance Therapy After First-Line Treatment in Metastatic Colorectal Cancer

NCT05659290 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-01-06

No results posted yet for this study

Summary

This is an open-label, multicenter, randomized parallel-group phase 2 study evaluating the efficacy and safety of Fruquintinib alternating with Bevacizumab plus Capecitabine versus Bevacizumab plus Capecitabine as maintenance therapy following first-line treatment for metastatic colorectal cancer. Approximately 40 patients with metastatic colorectal cancer who have achieved partial remission after completing 8 cycles of standard first-line chemotherapy (FOLFOX combined with Bevacizumab) but are still in un-resectable state will be assigned to 2 maintenance treatment groups by randomization in a 1:1 ratio to receive Fruquintinib alternating with Bevacizumab plus Capecitabine (Arm A) or Bevacizumab plus Capecitabine (Arm B). The study contains a safety lead-in phase in which the safety and efficacy of Fruquintinib alternating with Bevacizumab plus Capecitabine will be assessed in approximately 20 patients. All patients from Arm A and Arm B will be treated until unacceptable toxicity, withdrawal of informed consent, death, or other criteria for ending the study (whichever occurs earlier). The study will evaluate PFS, ORR, DCR, OS and safety.

Conditions

Interventions

DRUG

Fruquintinib alternating with Bevacizumab plus Capecitabine

Maintenance therapy with Fruquintinib 5mg, orally, once daily, d1-14, 2 weeks on/ 1 week off, q3w, followed by Bevacizumab 7.5 mg/kg, iv.gtt,d1,q3w + Capecitabine 850 mg/m2, orally, twice daily, d1-14, q3w; every 6 weeks as a treatment cycle; until unacceptable toxicity, withdrawal of informed consent, death, or other criteria for ending the study (whichever occurs earlier).

DRUG

Bevacizumab plus Capecitabine

Maintenance therapy with Bevacizumab 7.5 mg/kg, iv.gtt,d1,q3w + Capecitabine 850 mg/m2, orally, twice daily, d1-14, q3w; every 3 weeks as a treatment cycle; until unacceptable toxicity, withdrawal of informed consent, death, or other criteria for ending the study (whichever occurs earlier).

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05659290 on ClinicalTrials.gov