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Study of Fuquinitinib Combined With Capecitabine First-line Maintenance in the Treatment of Metastatic Colorectal Cancer

NCT06115733 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-11-03

No results posted yet for this study

Summary

This is a single-arm, single-center, prospective phase I/II study that received standard first-line chemotherapy (FOLFOX,FOLFIRI,XELOX, FOLFOXIRI± targeted therapy). If the first-line chemotherapy regimen is a 2-week regimen, patients need to undergo ≥8 cycles of standard chemotherapy. If the first-line chemotherapy regimen is a 3-week regimen, maintenance therapy is required for patients with unresectable advanced metastatic colorectal cancer who have reached CR,PR,SD (RECIST 1.1) after standard chemotherapy after ≥4 cycles.

The eligible patients were screened for maintenance treatment. Maintenance therapy research is divided into the following two phases:

Phase IIB fuquinitinib combined capecitabine dose exploration trial (n=6-9) : Phase II: Dose extension trial (n=47) : 47 patients were continued to be enrolled in the dose extension phase trial according to the recommended dose of fuquinitinib combined with capecitabine established in phase iB, and were treated until toxicity became intolerable or disease progression.

Conditions

  • Colorectal Carcinoma

Interventions

DRUG

Fruquintinib、Capecitabine Tablets

Phase Ⅰb dose exploration trial of fuquinitinib combined with capecitabine (n=6-9) : 3\) Capecitabine: 1000 mg/m² orally, twice a day on days 1-21 of each cycle, 28 days for one treatment cycle. 4\) Fuquinitinib: 1 to 21 days per cycle, orally, once a day, 28 days for a treatment cycle. There are two dose gradients of fuquintinib: 2mg/d, and the initial dose of 3mg/d is 2mg/d. According to the 3+3 dose climbing principle, dose exploration is carried out in the order of 2mg/d→3mg/d, as follows: Phase II: Dose extension trial (n=47) : The recommended dose of fuquinitinib combined with capecitabine, as determined in phase I b, continued to enroll 47 patients in the dose-expansion phase trial until the patient became intolerant of toxicity or disease progression.

Sponsors & Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-12-28
Primary Completion
2026-12-15
Completion
2026-12-31

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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 NCT06115733 on ClinicalTrials.gov