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This study was a phase 2, single-arm, single-center clinical trial in which previously treated patients with unresectable colorectal cancer liver metastases.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| overall progression-free survival (PFS) | PFS is defined as the time from the initiation of treatment until disease progression or death. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meng Qiu, Professor | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25970050 | Background | 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. | |
| 37639032 |
| Label | URL |
|---|---|
| Pubmed Official website | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Statistical analysis | Analytic Code | View IPD |
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2023 | Jun 9, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 1, 2023 | Jun 9, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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|
DoR was defined as time from first occurrence of complete or partial response until date of radiographical disease progression or death, whichever occurred first. |
| 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. | 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. | 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. | 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. |
| 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. |
| 37133585 | 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. |
| 25981818 | 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. |
| 26578731 | 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. |
| 29946728 | 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. |
The Kaplan-Meier method was used to analyze OS and PFS in the overall population with estimated medians and 95% CIs presented. Survival curves were performed using R software version 4.2.2 (http://www.Rproject.org). |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |