CompletedPhase 2

FOLFOXIRI-based HAIC Combined With Fuquintinib as Late-line Treatment in Patients With CRLM：A Phase 2 Single-Arm Clinical Trial

China44 participantsStarted 2023-01-12

Plain-language summary

This study was a phase 2, single-arm, single-center clinical trial in which previously treated patients with unresectable colorectal cancer liver metastases.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 18 and 75 years; * Histologically or cytologically confirmed CRLM; * Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2; * Prior failure of at least second-line of systemic therapy (fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy regimens, anti-EGFR therapy for RAS wild-type tumors and/or anti-VEGF therapy); * At least one measurable intrahepatic target lesion according to RECIST V1.1 criteria; * Normal major organ function(liver, kidney, heart, and lungs); * Patients with limited extrahepatic metastases (defined as up to 3 metastatic lesions in a single organ system) were eligible for inclusion. Exclusion Criteria: * Previous treatment with transarterial chemoembolization (TACE) or HAIC; prior use of fruquintinib; * A history of another malignancy within 5 years prior to enrollment, except for adequately treated non-melanoma skin cancer or in situ carcinoma, carcinoma in situ of the cervix, or gastrointestinal tumors treated curatively with endoscopic mucosal resection; * Allergy to the study drug; * Severe dysfunction of major organs (liver, kidney, heart, or lungs).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

objective response rate

Timeframe: The best evaluation of clinical efficacy from the time of the first initiation of treatment until the patient's disease progression to change of treatment or death, assessed up to 100 months.

Trial details

NCT IDNCT07024537

SponsorMeng Qiu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-30

View on ClinicalTrials.gov More Colorectal Neoplasms trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.