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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Study population:

Patients who meet all inclusion criteria and none of the exclusion criteria are eligible for enrolment and study treatment.

Inclusion criteria:

1. Age ≥ 18 years old;
2. Histopathologically confirmed CRC adenocarcinoma;
3. Locally advanced CRC confirmed as clinical T4 stage on CT/MRI imaging, with or without synchronous liver metastases;
4. 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.
5. No prior administration of chemotherapy, targeted therapy or radiotherapy for the current malignancy;
6. 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;
7. Estimated survival is more than 3 months;
8. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;
9. All the patients in this study are required to sign an informed consent form.

Exclusion criteria:

1. Patients have other primary malignant tumors;
2. Patients with recurrent CRC;
3. Patients with distant metastases besides synchronous hepatic metastases (e.g., pulmonary, bone, or brain metastases);
4. For patients with CRLM, the MDT consensus recommends a liver-first treatment strategy to avoid the risk of rapid hepatic lesion progression;
5. CRC patients with gastrointestinal perforation
6. Patients with malignant bowel obstruction refractory to conservative management;
7. Patients are allergic to the antitumor agents;
8. Women pregnant, breastfeeding or planning to become pregnant;
9. Patients receiving other antitumor therapies, such as chemotherapy, targeted therapy or radiotherapy;
10. Patients with MSI-H/dMMR CRC.

Where it's running

• 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
• Email: hnzyydxwjp@163.com
• Phone: 01088001037

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.