Clinical Efficacy of Transarterial Infusion Chemotherapy for Unresectable Colorectal Cancer

NCT07333053 | Recruiting DMC

• 1 other identifier: 2025-268-KY
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multicenter, randomized, open-label clinical trial. It aims to investigate whether intensive transarterial infusion chemotherapy (TAIC) followed by sequential intravenous chemotherapy (IVC) is clinically more effective than IVC alone in the treatment of unresectable colorectal cancer (uCRC).

Conditions

Unresectable Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Objective response rate is defined as the percentage of patients achieving complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 for CRC and modified RECIST criteria for CRLM.

  8 weeks

Secondary Outcomes (6)

• Health-related quality of life

  8 weeks

• Clinical complete response

  8 weeks

• Pathological complete response

  8 weeks

• The rate of conversion to resectable status

  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 receive FOLFOX-based TAIC at Week 0 and Week 4 and receive FOLFOX-based IVC at Week 2 and Week 6. The FOLFOX-based TAIC consists of oxaliplatin (85 mg/m²) and leucovorin (400 mg/m²), each administered as a 2-hour transarterial infusion, and fluorouracil (2400 mg/m²) administered as a 44-hour continuous transarterial infusion. Before placing a microcatheter into the feeding artery of the CRC, transarterial chemoembolization is performed for the liver metastases in patients with CRLM. The iodized oil emulsion is prepared by mixing 4 mL of iodized oil with 20 mg of oxaliplatin powder. Through the microcatheter, 0.5 mL of the iodized oil emulsion is slowly injected into the liver tumors via the feeding arterial branches. The technical endpoint of embolization is the absence of additional tumor staining or stasis/near stasis of the tumor-feeding arteries. The IVC and targeted therapy regimens are the same as those in the IVC group.

Procedure: Transarterial infusion chemotherapy (TAIC)

IVC group

ACTIVE COMPARATOR

Patients in the IVC group will receive FOLFOX-based IVC every 2 weeks for a total duration of 8 weeks. The FOLFOX regimen consists of oxaliplatin (85 mg/m²) and leucovorin (400 mg/m²), each administered as a 2-hour intravenous infusion, and fluorouracil (2400 mg/m²) administered as a 44-hour continuous intravenous infusion. For patients with CRLM, targeted therapy will be selected according to RAS/BRAF status and primary tumor side. Cetuximab will be administered by intravenous injection for the treatment of RAS/BRAF wild-type left-sided CRLM. Bevacizumab will be administered by intravenous injection for the treatment of RAS/BRAF wild-type right-sided CRLM and RAS/BRAF mutant CRLM irrespective of primary tumor location.

Procedure: Intravenous Chemotherapy（IVC）

Interventions

Intravenous Chemotherapy（IVC） PROCEDURE

Intravenous administration of chemotherapeutic agents is the mainstay of chemotherapy.

IVC group

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

Eligibility Criteria

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

You may not qualify if:

• Age ≥ 18 years old;
• Histopathologically confirmed CRC adenocarcinoma;
• Locally advanced CRC confirmed as clinical T4 stage on CT/MRI imaging, with or without synchronous liver metastases;
• For patients with CRLM, hepatic tumor burden shall be lower than the burden of the primary colorectal lesion. Consequently, the multidisciplinary team (MDT) agree by consensus that CRC should be a priority target for treatment.
• No prior administration of chemotherapy, targeted therapy or radiotherapy for the current malignancy;
• Adequate haematological, heart, liver and renal functions are required, with the following specific criteria: white blood cell count≥4×109 /L, neutrophils≥1.5×109 /L, platelets≥100×10⁹ /L, haemoglobin≥100 g/L, total bilirubin≤34.2 μmol/L, aspartate aminotransferase≤100 IU/L, alanine aminotransferase≤100 IU/L, serum creatinine ≤133 μmol/L or creatinine clearance rate≥60 mL/min, and urine protein/creatinine\<1;
• Estimated survival is more than 3 months;
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;
• All the patients in this study are required to sign an informed consent form.
• Patients have other primary malignant tumors;
• Patients with recurrent CRC;
• Patients with distant metastases besides synchronous hepatic metastases (e.g., pulmonary, bone, or brain metastases);
• For patients with CRLM, the MDT consensus recommends a liver-first treatment strategy to avoid the risk of rapid hepatic lesion progression;
• CRC patients with gastrointestinal perforation
• Patients with malignant bowel obstruction refractory to conservative management;

Sponsors & Collaborators

• Affiliated Hospital of Hebei University: collaborator
• The Shanghai Yangpu Central Hospital: collaborator
• Liaoning Cancer Hospital & Institute: collaborator
• Baoding Mancheng District People's Hospital: collaborator
• The Rocket Force Characteristic Medical Center: collaborator
• Second Affiliated Hospital of Nanchang 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
• Hebei Yixian Hospital: collaborator
• The First People's Hospital of Jiujiang City: collaborator
• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

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: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 12, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-09

Locations

CN (1)