NCT06115733

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

A Single-arm, Single-center, Prospective Phase I/II Study of Fuquinitinib Combined With Capecitabine First-line Maintenance in the Treatment of Metastatic Colorectal Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-12-28
• Primary completion: 2026-12-15
• Completion: 2026-12-31
• First posted: 2023-11-03
• Last updated: 2023-11-03