FOLFOXIRI-based HAIC Combined With Fuquintinib as Late-line Treatment in Patients With CRLM：A Pha… (NCT07024537) | Clinical Trial Compass
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 range18 Years – 75 Years
SexALL
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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).
What they're measuring
1
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.