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

NCT07024537 | Completed Phase 2

• 1 other identifier: Approval No. 380, 2023
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• objective response rate

  ORR is defined as the proportion of patients with the best overall response of CR or PR among all participants.

  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.

Secondary Outcomes (5)

• overall progression-free survival (PFS)

  From date of the first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.

• Duration of Response(DoR)

  From date of first occurrence of complete or partial response until date of radiographical disease progression or death, whichever occurred first. the assessed up to 100 months.

• Disease control rate(DCR)

  From date of the first treatment until the date of date of death from any cause or experiment stopped, whichever came first, assessed up to 100 months.

• Overall survival (OS)

  From date of the first treatment until the date of date of death from any cause, whichever came first, assessed up to 100 months.

• Liver-specific PFS

  From date of the first treatment until the date of first documented liver progression or date of death from any cause, whichever came first, assessed up to 100 months.

Study Arms (1)

A Phase II Single-Arm Clinical Trial

EXPERIMENTAL

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.

Drug: FOLFOXIRI-based HAIC+Fuquinitinib

Interventions

FOLFOXIRI-based HAIC+Fuquinitinib DRUG

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, and FOLFOXIRI-HAIP chemotherapy with 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.

A Phase II Single-Arm Clinical Trial

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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).

Sponsors & Collaborators

• Meng Qiu: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (6)

• Mayer 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 BACKGROUND

• Verheij 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 BACKGROUND

• Prager 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 BACKGROUND

• Li 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 BACKGROUND

• Levi 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.

  PMID: 26578731 BACKGROUND

• Li J, Qin S, Xu RH, Shen L, Xu J, Bai Y, Yang L, Deng Y, Chen ZD, Zhong H, Pan H, Guo W, Shu Y, Yuan Y, Zhou J, Xu N, Liu T, Ma D, Wu C, Cheng Y, Chen D, Li W, Sun S, Yu Z, Cao P, Chen H, Wang J, Wang S, Wang H, Fan S, Hua Y, Su W. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018 Jun 26;319(24):2486-2496. doi: 10.1001/jama.2018.7855.

  PMID: 29946728 BACKGROUND

Related Links

• Pubmed Official website

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Meng Qiu, Professor

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 17, 2025
• Study Start: January 12, 2023
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: April 30, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)