Clinical Efficacy of Transarterial Infusion Chemotherapy for Unresectable Colorectal Cancer

FOLFOX-Based Transarterial Infusion Chemotherapy for Unresectable Colorectal Cancer: An Open-Label, Multicenter, Randomized, Controlled, Phase Ⅱ Trial

This is a prospective, multicenter, randomized, and open-label clinical trial. It is initiated to determine the efficacy of FOLFOX-based, transarterial infusion chemotherapy (TAIC) combined with either cetuximab or bevacizumab for patients with unresectable colorectal cancer (CRC).

Study Overview

• Status: Recruiting
• Conditions: Unresectable Colorectal Cancer
• Intervention / Treatment: Procedure: Transarterial infusion chemotherapy (TAIC); Procedure: Intravenous Chemotherapy（IVC）

Detailed Description

Current CRC treatment options include surgical resection, intravenous chemotherapy (IVC), radiation therapy, immunotherapy, and targeted therapy, or a combination of these options. IVC is an important therapy for CRC. Unfortunately, IVC results in broad drug distribution, while achieving with relatively low drug accumulation within the tumor. Compared with IVC, TAIC can increase the local intra-tumoral concentrations of chemotherapeutic agents by intensifying drug delivery into the tumor via super-selective catheterization of the tumor-feeding artery, and meanwhile reduce systematic toxicity. Hepatic artery infusion chemotherapy (HAIC) has been shown to yield significantly better outcomes than conventional transarterial chemoembolization (TACE) or IVC, and is now widely used for primary liver cancer and secondary liver malignancies. Based on these experiences, the investigators hypothesize that TAIC is clinically more effective at the same dose than IVC in the treatment of unresectable CRC. However, there is currently no high-quality evidence from clinical trials to support this hypothesis. To address this gap, the investigators will conduct a prospective study to verify this hypothesis. Eligible patients are those with unresectable CRC, those intolerant to surgical resection, and those with microsatellite instability or microsatellite instability low or proficient mismatch repair CRC. A total of 30 patients will be randomly assigned to the IVC group or TAIC group. Patients in the IVC group will receive the FOLFOX-based IVC with either cetuximab or bevacizumab every two weeks for a total of 8 weeks. Patients in the TAIC group will undergo FOLFOX-based TAIC combined with either cetuximab or bevacizumab on weeks 0 and 4 and will receive FOLFOX-based IVC with either cetuximab or bevacizumab on weeks 2 and 6. The primary endpoints are the objective response rate (ORR) and disease control rate (DCR).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Quanda Liu Chief physician, MD; Phone Number: 01088001037; Email: hnzyydxwjp@163.com
• Study Contact Backup: Name: Junpeng Wang, MD; Email: hnzyydxwjp@163.com

Study Locations

• China
  • Beijing Municipality
    • Xicheng, Beijing Municipality, China, 100053
      • Recruiting
      • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
      • Contact: Quanda Liu Chief physician, MD; Phone Number: 01088001037; Email: hnzyydxwjp@163.com
      • Contact: Email: hnzyydxwjp@163.com
      • Principal Investigator: Liuxin Duan, MD
      • Principal Investigator: Li Yao, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years;
2. Colorectal cancer confirmed by CT/MRI and colonoscopic biopsy；
3. Patients unfit for surgery due to poor general condition or tumor extent and location;
4. Patients who have not received prior chemotherapy or those who have undergone prior chemotherapy but remain chemosensitive.
5. Adequate haematological, heart, liver and renal functions are required, with the following specific criteria: white blood cell count≥4000/mL, neutrophils≥1500/mm³, platelets≥100×10⁹/L, haemoglobin≥10.0 g/L, total bilirubin 2.0 mg/dL, aspartate aminotransferase 100 IU/L, alanine aminotransferase 100 IU/L, serum creatinine 1.5 mg/dL or creatinine clearance rate≥60 mL/min/body, and urine protein/creatinine<1.
6. Patients have to have an expected life expectancy of ≥3months.
7. All the subjects in this study are required to sign an informed consent form.

Exclusion Criteria:

1. Patients with other primary malignant tumors;
2. Patients with gastrointestinal perforation;
3. Patients are allergic to the antitumor agents;
4. Women who are pregnant, breastfeeding, or planning to become pregnant;
5. Patients who receive other antitumor therapies concurrently, such as chemotherapy, targeted therapy, or radiotherapy;
6. Patients with MSI-H/dMMR CRC；
7. Patients for whom participation in the study is deemed to be inappropriate by the doctor in charge and/or the investigator for any other reasons.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAIC Group; Patients in the TAIC group will undergo FOLFOX-based TAIC combined with either cetuximab or bevacizumab on weeks 0 and 4, and will receive FOLFOX-based IVC combined with either cetuximab or bevacizumab on weeks 2 and 6. During each TAIC, based on the tumor's vaIVCular supply, the Seldinger technique is used to puncture the right femoral artery, and a microcatheter is inserted into the arterial branch of the superior mesenteric artery, inferior mesenteric artery, or common iliac artery, which is predominantly feeding the tumor. Chemotherapy drugs will be administered via the microcatheter. The FOLFOX-based TAIC consists of oxaliplatin (85 mg/m²) administered as a 2 hours transarterial infusion, leucovorin (400 mg/m²) administered as a 2 hours transarterial infusion, and fluorouracil (2400 mg/m²) administered as a 44 hours transarterial infusion, followed by intravenous administration of bevacizumab (5 mg/kg) or cetuximab (500 mg/m²). The IVC regimen is the same as that in the IVC group	Procedure: Transarterial infusion chemotherapy (TAIC); TAIC can increase the local intra-tumoral concentrations of chemotherapeutic agents by intensifying drug delivery into the tumor via super-selective catheterization of the tumor-feeding artery, and meanwhile reduce systematic toxicity.
Active Comparator: IVC group; Patients in the IVC group will receive FOLFOX-based IVC combined with either cetuximab or bevacizumab every two weeks for a total of 8 weeks. The FOLFOX regimen consists of oxaliplatin (85 mg/m²) administered as a 2 hours intravenous infusion, leucovorin (400 mg/m²) administered as a 2 hours intravenous infusion, and fluorouracil (2400 mg/m²) administered as a 44 hours intravenous infusion, followed by intravenous administration of bevacizumab (5 mg/kg) or cetuximab (500 mg/m²). Cetuximab is used for the treatment of RAS/BRAF wild-type left-sided CRC, while bevacizumab is used for the treatment of RAS/BRAF wild-type right-sided CRC and RAS/BRAF mutant CRC regardless of tumor location.	Procedure: Intravenous Chemotherapy（IVC）; Intravenous administration of chemotherapeutic agents is the mainstay of chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	ORR is defined as the percentage of complete response and partial response that is maintained for at least 4 weeks from the first radiological confirmation.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of conversion to resectable status	The assessment of surgical resectability by an experienced and dedicated multidisciplinary team is required at each tumor assessment.	8 weeks
Clinical complete response	Clinical complete response is defined as no visible tumor on imaging examination.	8 weeks
Pathological complete response	The pathological complete response is defined as the absence of invasive neoplastic cells upon microscopic examination of the primary tumor during surgery.	8 weeks
Overall survival	Overall survival is calculated from the date of randomisation until death. Participants who are alive at the time of analysis were censored at the date of the latest time seen alive.	3 years
Health-related quality of life	Health-related quality of life was assessed using the European Organization for Research and Treatment of Cancer (EORTC) 30-item QoL Questionnaire (EORTC QLQ-C30). The EORTC QLQ-C30 consists of 30 items covering five functioning scales (physical, social, emotional, role, and cognitive), nine symptom scales (fatigue, nausea/vomiting, pain, dyspnea, sleep disturbances, appetite loss, constipation, diarrhea, and financial impact), and a global health status scale. Referring to a recall period of one-week (except for physical function, which does not refer to a recall period at all), patients indicate their answers on a 4-point Likert scale. Linear converted scale scores range from 0 to 100. Higher scores on the functioning scales and on the global health status scale indicate better functioning, whereas higher scores on the symptom scales indicate greater symptom burden.	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Adverse events are defined that newly appeared, increased in frequency, or worsened in severity following initiation of study drug. Adverse events were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 6.0.	8 weeks

Collaborators and Investigators

• Sponsor: Quanda Liu
• Collaborators: Second Affiliated Hospital of Nanchang University; Changzhi Medical College; The First Hospital of Qinhuangdao; Liaoning Cancer Hospital & Institute; The Rocket Force Characteristic Medical Center; The Affiliated Hospital of Hebei University; The Central Hospital of Handan City; The First People's Hospital of Jiujiang City; Zibo Boshan District Traditional Chinese Medicine Hospital; Linshu County People's Hospital; Hebei Yixian Hospital; Baoding Mancheng District People's Hospital
• Investigators: Principal Investigator: Quanda Liu, MD, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: December 31, 2025
• First Posted (Actual): January 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Bevacizumab; Unresectable; Colorectal Cancer; Cetuximab; Clinical Trial; Transarterial Infusion Chemotherapy; FOLFOX Protocol
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2025-268-KY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: At present, this study remains in the active implementation phase. Given that individual participant data (IPD) contains sensitive personal privacy information of research subjects, the investigators will not share the IPD with external researchers temporarily, in order to strictly comply with ethical requirements and fully protect the legitimate rights and interests of study participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No