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RecruitingNot ApplicableNCT07333053

Clinical Efficacy of Transarterial Infusion Chemotherapy for Unresectable Colorectal Cancer

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

Sponsor

Quanda Liu

Enrollment

30 participants

Start Date

Mar 31, 2026

Study Type

INTERVENTIONAL

Conditions

Unresectable Colorectal Cancer

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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.

Exclusion Criteria7

  • 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.

Interventions

PROCEDURETransarterial infusion chemotherapy (TAIC)

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.

PROCEDUREIntravenous Chemotherapy（IVC）

Intravenous administration of chemotherapeutic agents is the mainstay of chemotherapy.

Locations(1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Xicheng, Beijing Municipality, China

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NCT07333053