Clinical trial · Interventional
FOLFOXIRI-based HAIC Combined With Fuquintinib as Late-line Treatment in Patients With CRLM：A Phase 2 Single-Arm Clinical Trial
FOLFOXIRI-based Hepatic Arterial Infusion Combined With Fuquintinib as Late-line Treatment in Patients With Colorectal Cancer Liver Metastase: A Phase 2 Single-Arm Clinical Trial
NCT07024537CI-TRIAL-00109982HAIC，CRLMcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study was a phase 2, single-arm, single-center clinical trial in which previously treated patients with unresectable colorectal cancer liver metastases.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFOXIRI-based HAIC+Fuquinitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A Phase II Single-Arm Clinical Trial
- description
- all enrolled patients without surgical contraindications underwent hepatic artery port implantation by an interventional physician.All patients received oral fruquintinib at an initial dose of 4 mg once daily from day 1 to day 21 of each 28-day cycle. Patients received drug infusion via the hepatic artery: Oxaliplatin 85 mg/m² and Leucovorin 400 mg/m² infused via arterial pump over 2 hours on day 1, Irinotecan 150 mg/m² infused via arterial pump over 90 minutes on day 1,and 5-Fluorouracil 2400 mg/m² infused via arterial pump over 46 hours, repeated biweekly until disease progression, patient's refusal, unacceptable toxic effects, or withdrawal of consent.
- interventionNames
- Drug: FOLFOXIRI-based HAIC+Fuquinitinib
Primary outcomes (1)
- measure
- 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.
- description
- ORR is defined as the proportion of patients with the best overall response of CR or PR among all participants.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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).
References
Publications (6)
- BACKGROUNDMayer RJ, Van Cutsem E, Falcone A, Yoshino T, Garcia-Carbonero R, Mizunuma N, Yamazaki K, Shimada Y, Tabernero J, Komatsu Y, Sobrero A, Boucher E, Peeters M, Tran B, Lenz HJ, Zaniboni A, Hochster H, Cleary JM, Prenen H, Benedetti F, Mizuguchi H, Makris L, Ito M, Ohtsu A; RECOURSE Study Group. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015 May 14;372(20):1909-19. doi: 10.1056/NEJMoa1414325. PMID 25970050
- BACKGROUNDVerheij FS, Kuhlmann KFD, Silliman DR, Soares KC, Kingham TP, Balachandran VP, Drebin JA, Wei AC, Jarnagin WR, Cercek A, Kok NFM, Kemeny NE, D'Angelica MI. Combined Hepatic Arterial Infusion Pump and Systemic Chemotherapy in the Modern Era for Chemotherapy-Naive Patients with Unresectable Colorectal Liver Metastases. Ann Surg Oncol. 2023 Dec;30(13):7950-7959. doi: 10.1245/s10434-023-14073-3. Epub 2023 Aug 28. PMID 37639032
- BACKGROUNDPrager GW, Taieb J, Fakih M, Ciardiello F, Van Cutsem E, Elez E, Cruz FM, Wyrwicz L, Stroyakovskiy D, Papai Z, Poureau PG, Liposits G, Cremolini C, Bondarenko I, Modest DP, Benhadji KA, Amellal N, Leger C, Vidot L, Tabernero J; SUNLIGHT Investigators. Trifluridine-Tipiracil and Bevacizumab in Refractory Metastatic Colorectal Cancer. N Engl J Med. 2023 May 4;388(18):1657-1667. doi: 10.1056/NEJMoa2214963. PMID 37133585
- BACKGROUNDLi J, Qin S, Xu R, Yau TC, Ma B, Pan H, Xu J, Bai Y, Chi Y, Wang L, Yeh KH, Bi F, Cheng Y, Le AT, Lin JK, Liu T, Ma D, Kappeler C, Kalmus J, Kim TW; CONCUR Investigators. Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2015 Jun;16(6):619-29. doi: 10.1016/S1470-2045(15)70156-7. Epub 2015 May 13. PMID 25981818
- BACKGROUNDLevi FA, Boige V, Hebbar M, Smith D, Lepere C, Focan C, Karaboue A, Guimbaud R, Carvalho C, Tumolo S, Innominato P, Ajavon Y, Truant S, Castaing D, De Baere T, Kunstlinger F, Bouchahda M, Afshar M, Rougier P, Adam R, Ducreux M; Association Internationale pour Recherche sur Temps Biologique et Chronotherapie (ARTBC International). Conversion to resection of liver metastases from colorectal cancer with hepatic artery infusion of combined chemotherapy and systemic cetuximab in multicenter trial OPTILIV. Ann Oncol. 2016 Feb;27(2):267-74. doi: 10.1093/annonc/mdv548. Epub 2015 Nov 16.