Clinical Efficacy of Transarterial Infusion Chemotherapy for Unresectable Colorectal Cancer

NCT07333053 | Recruiting DMC

• 1 other identifier: 2025-268-KY
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Unresectable Colorectal Cancer

Keywords

Transarterial Infusion Chemotherapy; Bevacizumab; Cetuximab; Colorectal Cancer; FOLFOX Protocol; Unresectable; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Health-related quality of life

  8 weeks

• Clinical complete response

  8 weeks

• The rate of conversion to resectable status

  8 weeks

• Pathological complete response

  8 weeks

• Overall survival

  3 years

Other Outcomes (1)

• Adverse events

  8 weeks

Study Arms (2)

TAIC Group

EXPERIMENTAL

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)

IVC group

ACTIVE COMPARATOR

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）

Interventions

Transarterial infusion chemotherapy (TAIC) PROCEDURE

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.

TAIC Group

Intravenous Chemotherapy（IVC） PROCEDURE

Intravenous administration of chemotherapeutic agents is the mainstay of chemotherapy.

IVC group

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years;
• Colorectal cancer confirmed by CT/MRI and colonoscopic biopsy；
• Patients unfit for surgery due to poor general condition or tumor extent and location;
• Patients who have not received prior chemotherapy or those who have undergone prior chemotherapy but remain chemosensitive.
• 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.
• Patients have to have an expected life expectancy of ≥3months.
• All the subjects in this study are required to sign an informed consent form.

You may not qualify if:

• Patients with other primary malignant tumors;
• Patients with gastrointestinal perforation;
• Patients are allergic to the antitumor agents;
• Women who are pregnant, breastfeeding, or planning to become pregnant;
• Patients who receive other antitumor therapies concurrently, such as chemotherapy, targeted therapy, or radiotherapy;
• Patients with MSI-H/dMMR CRC；
• 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.

Sponsors & Collaborators

• Quanda Liu: lead
• Liaoning Cancer Hospital & Institute: collaborator
• The Rocket Force Characteristic Medical Center: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• The Affiliated Hospital of Hebei University: collaborator
• The First Hospital of Qinhuangdao: collaborator
• The Central Hospital of Handan City: collaborator
• Changzhi Medical College: collaborator
• Zibo Boshan District Traditional Chinese Medicine Hospital: collaborator
• Linshu County People's Hospital: collaborator
• Hebei Yixian Hospital: collaborator
• Baoding Mancheng District People's Hospital: collaborator
• The First People's Hospital of Jiujiang City: collaborator

Study Sites (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Xicheng, Beijing Municipality, 100053, China

RECRUITING

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

• Quanda Liu, MD

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quanda Liu Chief physician, MD

CONTACT

01088001037; hnzyydxwjp@163.com

Junpeng Wang, MD

CONTACT

hnzyydxwjp@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 12, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

CN (1)