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RECRUITING Not applicable ClinicalTrials.gov

Clinical Efficacy of Transarterial Infusion Chemotherapy for Unresectable Colorectal Cancer

Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences • ClinicalTrials.gov ID: NCT07333053

Registry updated: 2026-09-11
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Description

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).

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.
  • Intravenous Chemotherapy(IVC) (Procedure)
    Intravenous administration of chemotherapeutic agents is the mainstay of chemotherapy.

Eligibility criteria

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.

Conditions

Unresectable Colorectal Cancer

Locations

  • Guang'anmen Hospital, China Academy of Chinese Medical Sciences — Xicheng, Beijing Municipality, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record