Clinical Efficacy of Transarterial Infusion Chemotherapy for Unresectable Colorectal Cancer

Quanda Liu

Status: Enrolling

Conditions: Unresectable Colorectal Cancer

Treatments: Procedure: Transarterial infusion chemotherapy (TAIC); Procedure: Intravenous Chemotherapy（IVC）

Study type: Interventional

Funder types: Other

Identifiers

NCT07333053

2025-268-KY

Details and patient eligibility

About

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).

Full description

Current CRC treatment options include surgical resection, intravenous chemotherapy (IVC), radiation therapy, immunotherapy, and targeted therapy, or a combination of these options. IVC is an important therapy for CRC. Unfortunately, IVC results in broad drug distribution, while achieving with relatively low drug accumulation within the tumor. Compared with IVC, 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. Hepatic artery infusion chemotherapy (HAIC) has been shown to yield significantly better outcomes than conventional transarterial chemoembolization (TACE) or IVC, and is now widely used for primary liver cancer and secondary liver malignancies. Based on these experiences, the investigators hypothesize that TAIC is clinically more effective at the same dose than IVC in the treatment of unresectable CRC. However, there is currently no high-quality evidence from clinical trials to support this hypothesis. To address this gap, the investigators will conduct a prospective study to verify this hypothesis. Eligible patients are those with unresectable CRC, those intolerant to surgical resection, and those with microsatellite instability or microsatellite instability low or proficient mismatch repair CRC. A total of 30 patients will be randomly assigned to the IVC group or TAIC group. Patients in the IVC group will receive the FOLFOX-based IVC with either cetuximab or bevacizumab every two weeks for a total of 8 weeks. Patients in the TAIC group will undergo FOLFOX-based TAIC combined with either cetuximab or bevacizumab on weeks 0 and 4 and will receive FOLFOX-based IVC with either cetuximab or bevacizumab on weeks 2 and 6. The primary endpoints are the objective response rate (ORR) and disease control rate (DCR).

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

TAIC Group

Experimental group

Description:

Patients in the TAIC group will undergo FOLFOX-based TAIC combined with either cetuximab or bevacizumab on weeks 0 and 4, and will receive FOLFOX-based IVC combined with either cetuximab or bevacizumab on weeks 2 and 6. During each TAIC, based on the tumor's vaIVCular supply, the Seldinger technique is used to puncture the right femoral artery, and a microcatheter is inserted into the arterial branch of the superior mesenteric artery, inferior mesenteric artery, or common iliac artery, which is predominantly feeding the tumor. Chemotherapy drugs will be administered via the microcatheter. The FOLFOX-based TAIC consists of oxaliplatin (85 mg/m²) administered as a 2 hours transarterial infusion, leucovorin (400 mg/m²) administered as a 2 hours transarterial infusion, and fluorouracil (2400 mg/m²) administered as a 44 hours transarterial infusion, followed by intravenous administration of bevacizumab (5 mg/kg) or cetuximab (500 mg/m²). The IVC regimen is the same as that in the IVC group

Treatment:

Procedure: Transarterial infusion chemotherapy (TAIC)

IVC group

Active Comparator group

Description:

Patients in the IVC group will receive FOLFOX-based IVC combined with either cetuximab or bevacizumab every two weeks for a total of 8 weeks. The FOLFOX regimen consists of oxaliplatin (85 mg/m²) administered as a 2 hours intravenous infusion, leucovorin (400 mg/m²) administered as a 2 hours intravenous infusion, and fluorouracil (2400 mg/m²) administered as a 44 hours intravenous infusion, followed by intravenous administration of bevacizumab (5 mg/kg) or cetuximab (500 mg/m²). Cetuximab is used for the treatment of RAS/BRAF wild-type left-sided CRC, while bevacizumab is used for the treatment of RAS/BRAF wild-type right-sided CRC and RAS/BRAF mutant CRC regardless of tumor location.

Treatment:

Procedure: Intravenous Chemotherapy（IVC）