New combo shrinks liver tumors in hard-to-treat colorectal cancer
NCT ID NCT07024537
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a treatment for people with colorectal cancer that spread to the liver and had not responded to at least two prior therapies. The treatment combined a strong chemotherapy cocktail delivered directly to the liver (FOLFOXIRI via hepatic arterial infusion) with an oral targeted drug called fuquintinib. The goal was to see how many patients' tumors shrank significantly. 44 patients took part in this single-arm phase 2 trial.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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44 people
The number who actually took part.
- Started
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Jan 2023
- Finished
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May 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
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Other studies related to the condition(s) this trial covers.
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