Clinical Efficacy of Transarterial Infusion Chemotherapy for Unresectable Colorectal Cancer
NCT ID: NCT07333053
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2026-01-31
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TAIC Group
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
Transarterial 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.
IVC group
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.
Intravenous Chemotherapy（IVC）
Intravenous administration of chemotherapeutic agents is the mainstay of chemotherapy.
Interventions
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Transarterial 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.
Intravenous Chemotherapy（IVC）
Intravenous administration of chemotherapeutic agents is the mainstay of chemotherapy.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Liaoning Cancer Hospital & Institute
OTHER
The Rocket Force Characteristic Medical Center
UNKNOWN
Second Affiliated Hospital of Nanchang University
OTHER
The Affiliated Hospital of Hebei University
UNKNOWN
The First Hospital of Qinhuangdao
OTHER_GOV
The Central Hospital of Handan City
UNKNOWN
The First People's Hospital of Jiujiang City
UNKNOWN
Changzhi Medical College
OTHER
Zibo Boshan District Traditional Chinese Medicine Hospital
UNKNOWN
Linshu County People's Hospital
UNKNOWN
Hebei Yixian Hospital
UNKNOWN
Baoding Mancheng District People's Hospital
UNKNOWN
Quanda Liu
OTHER
Responsible Party
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Quanda Liu
Chief physician
Principal Investigators
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Quanda Liu, MD
Role: PRINCIPAL_INVESTIGATOR
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Locations
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Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Xicheng, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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2025-268-KY
Identifier Type: -
Identifier Source: org_study_id
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