Colorectal NeoplasmsPhase 2HAIC，CRLMNCT07024537

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

A Phase 2 study testing FOLFOXIRI-based HAIC+Fuquinitinib in people with Colorectal Neoplasms, run by Meng Qiu at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Colorectal Neoplasms
What is being tested?: FOLFOXIRI-based HAIC+Fuquinitinib
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteChina
Study dates: 12 Jan 2023to 30 May 2025
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

China1 site

West China Hospital of Sichuan University
Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: 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

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

Read the detailed description

The aim of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy combined with fruquintinib in later treatment for colorectal cancer liver metastases. All patients received FOLFOXIRI-based HAIC chemotherapy and oral fruquintinib. The primary end point was objective response rate (ORR), and the secondary endpoints were disease control rate (DCR), the liver-specific ORR, overall survival (OS), progression-free survival (PFS), liver-specific PFS, duration of response(DoR)and safety.

Conditions: Colorectal Neoplasms
Being tested: FOLFOXIRI-based HAIC+Fuquinitinib
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FOLFOXIRI-based HAIC+FuquinitinibDrug
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.

Study groups in NCT07024537
Study group	Role	What they receive
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. Receives: Drug: FOLFOXIRI-based HAIC+Fuquinitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

objective response rate
ORR is defined as the proportion of patients with the best overall response of CR or PR among all participants.
Measured: 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)
PFS is defined as the time from the initiation of treatment until disease progression or death.
Measured: 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)
DoR was defined as time from first occurrence of complete or partial response until date of radiographical disease progression or death, whichever occurred first.
Measured: 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)
The proportion of patients with a best overall response of achieved complete response, partial response or stable disease.
Measured: 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)
OS was defined as the time from study enrollment to death from any cause.
Measured: 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
Liver-specific PFS was defined analogously to PFS, but considering only progression events occurring within the liver.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jan 202330 May 2025

First posted17 Jun 2025
Study start12 Jan 2023
Primary completion30 May 2025
Study completion30 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07024537
Sponsor's protocol ID: Approval No. 380, 2023
Acronym: HAIC，CRLM
Status last verified: Jan 2025
First submitted: 26 May 2025
Last updated: 30 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: First of all, there is a lack of sufficient funds or personnel to anonymize and maintain the data for a long time, such as the original imaging documents, which are difficult to organize compliance. Second, this study was an early exploratory study with small data size and high risk of identification. Finally, summary results are available after publication, and the data will be reassessed 5 years after the end of the study.

Publications

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.
PubMed 25970050
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.
PubMed 37639032
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.
PubMed 37133585
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.
PubMed 25981818
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.
PubMed 26578731
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.
PubMed 29946728

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Colorectal Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07024537
Acronym / sponsor ID: HAIC，CRLM / Approval No. 380, 2023
Conditions: Colorectal Neoplasms
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Meng QiuUniversity, hospital or other
Study start: 12 Jan 2023 (actual)
Primary completion: 30 May 2025 (actual)
Study completion: 30 May 2025 (actual)
First posted: 17 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
A Phase II Single-Arm Clinical Trial	Experimental	Drug: FOLFOXIRI-based HAIC+Fuquinitiniball 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (4 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FOLFOXIRI-based HAIC+FuquinitinibAll 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.	Drug	A Phase II Single-Arm Clinical Trial

Primary outcome

objective response rate
Time frame: 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.
ORR is defined as the proportion of patients with the best overall response of CR or PR among all participants.

5 secondary outcomes

overall progression-free survival (PFS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
Background: PubMed 25970050Mayer 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.
Background: PubMed 37639032Verheij 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.
Background: PubMed 37133585Prager 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.
Background: PubMed 25981818Li 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.
Background: PubMed 26578731Levi 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.
Background: PubMed 29946728Li 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.
Pubmed Official websiteLink provided by the sponsor.
Individual participant dataSharing planned: No. First of all, there is a lack of sufficient funds or personnel to anonymize and maintain the data for a long time, such as the original imaging documents, which are difficult to organize compliance. Second, this study was an early exploratory study with small data size and high risk of identification. Finally, summary results are available after publication, and the data will be reassessed 5 years after the end of the study.

Related trials for Colorectal Neoplasms

Not yet recruitingPhase 1
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Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Meng Qiu, Professor principal investigator

West China Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FOLFOXIRI-based HAIC+Fuquinitinib in people with Colorectal Neoplasms, run by Meng Qiu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

objective response rate (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07024537, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.