FOLFOX delivered into the tumor artery with cetuximab or bevacizumab versus standard IV FOLFOX for unresectable colorectal cancer

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

This trial tests whether giving FOLFOX directly into the artery feeding the tumor plus cetuximab or bevacizumab helps people with unresectable colorectal cancer more than standard intravenous FOLFOX chemotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences (Academic / other)
• Drugs / interventions: chemotherapy, cetuximab, bevacizumab, immunotherapy, radiation
• Locations: 1 site (Xicheng, Beijing Municipality)
• Trial ID: NCT07333053 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, randomized, open-label trial that will randomize 30 patients with unresectable colorectal cancer to either transarterial infusion chemotherapy (TAIC) or standard intravenous chemotherapy (IVC) using a FOLFOX backbone combined with cetuximab or bevacizumab. TAIC delivers chemotherapy via super-selective catheterization of the tumor-feeding artery to increase local drug concentration and potentially reduce systemic toxicity, while the control arm receives conventional IV delivery. Eligible patients are adults unfit for surgery or with unresectable disease who are chemo-naive or remain chemosensitive after prior therapy and meet standard organ-function criteria. The trial aims to compare clinical efficacy and safety outcomes between the two delivery methods to provide higher-quality evidence for TAIC in this population.

Who should consider this trial

Good fit: Adults (≥18) with unresectable colorectal cancer who are unfit for surgery, have adequate blood, liver, heart and kidney function, an expected life expectancy of at least three months, and who are chemo-naive or remain chemosensitive are ideal candidates.

Not a fit: Patients with other primary malignancies, gastrointestinal perforation, or severe organ dysfunction (or those whose tumors are resectable) are unlikely to benefit from inclusion in this protocol.

Why it matters

Potential benefit: If successful, the approach could improve tumor drug exposure and control with fewer systemic side effects compared with standard IV chemotherapy.

How similar studies have performed: Hepatic artery infusion approaches have shown benefit for liver cancers and metastases, but high-quality randomized evidence for transarterial infusion chemotherapy specifically in unresectable colorectal cancer is currently lacking.

Eligibility criteria

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.

Where this trial is running

Xicheng, Beijing Municipality

• Guang'anmen Hospital, China Academy of Chinese Medical Sciences — Xicheng, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Quanda Liu, MD — Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Study coordinator: Quanda Liu Chief physician, MD

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