NIPH Clinical Trials Search

FRUPITA study (WJOG23625G)

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Colorectal cance
Date of first enrollment	26/05/2026
Target sample size	540
Countries of recruitment
Study type	Interventional
Intervention(s)	Standard Dosing(Group A) Fruquintinib 5 mg once daily for 21 days, followed by 7 days off, repeated every cycle. Dose-Escalation Dosing (Group B) Fruquintinib 3-5 mg once daily for 21 days, followed by 7 days off, per cycle. Treatment starts at 3 mg/day in cycle 1. If dose-escalation criteria are met, the dose is increased by 1 mg/day in subsequent cycles, up to a maximum of 5 mg/day. No dose escalation is performed within a cycle.

Outcome(s)

Primary Outcome

P2:Disease control rate, P3:Overall survival

Secondary Outcome

P2:Objective response rate, 12-week treatment continuation rate, Adverse events, Dose intensity, Plasma drug concentration, Patient-reported outcomes (PRO), QOL P3:Progression-free survival, Response rate, Disease control rate, Time to treatment failure, 12-week treatment continuation rate, Adverse events, Grade =>3 adverse events, Treatment-related serious adverse events, Dose intensity, Plasma drug concentration, Cumulative dose of fruquintinib, PRO, QOL

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1)Histologically confirmed colorectal adenocarcinoma. 2)Unresectable Stage IV or recurrent colorectal cancer. 3)Age =>18 years on the date of consent. 4)ECOG PS 0-2(Phase II part: 0-1 only). 5)With measurable lesion(not required for Phase III part). 6)Refractory, intolerant,or unsuitable for standard treatments including fluoropyrimidine,oxaliplatin,irinotecan,anti-VEGF antibody,and anti-EGFR antibody (if indicated). Previous administration of trifluridine/tipiracil or regorafenib is not mandatory 7)No previous administration with fruquintinib 8)Ability to safely receive the protocol treatment. 9)Written informed consent obtained from the patient.
Exclude criteria	1)Pregnant or breastfeeding women, women who may be pregnant, or those not willing to use contraception. 2)Judged ineligible for trial participation by the investigator.