Clinical trial · Interventional
Clinical Efficacy of Transarterial Infusion Chemotherapy for Unresectable Colorectal Cancer
FOLFOX-Based Transarterial Infusion Chemotherapy for Unresectable Colorectal Cancer: Protocol of an Open-Label, Multicentre, Randomised, Controlled, Phase Ⅱ Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unresectable Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravenous Chemotherapy(IVC) | Procedure | — | UNRESOLVED |
| Transarterial infusion chemotherapy (TAIC) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TAIC Group
- description
- Patients in the TAIC group will receive FOLFOX-based TAIC at Week 0 and Week 4 and receive FOLFOX-based IVC at Week 2 and Week 6. The FOLFOX-based TAIC consists of oxaliplatin (85 mg/m²) and leucovorin (400 mg/m²), each administered as a 2-hour transarterial infusion, and fluorouracil (2400 mg/m²) administered as a 44-hour continuous transarterial infusion. Before placing a microcatheter into the feeding artery of the CRC, transarterial chemoembolization is performed for the liver metastases in patients with CRLM. The iodized oil emulsion is prepared by mixing 4 mL of iodized oil with 20 mg of oxaliplatin powder. Through the microcatheter, 0.5 mL of the iodized oil emulsion is slowly injected into the liver tumors via the feeding arterial branches. The technical endpoint of embolization is the absence of additional tumor staining or stasis/near stasis of the tumor-feeding arteries. The IVC and targeted therapy regimens are the same as those in the IVC group.
- interventionNames
- Procedure: Transarterial infusion chemotherapy (TAIC)
- type
- ACTIVE_COMPARATOR
- label
- IVC group
- description
- Patients in the IVC group will receive FOLFOX-based IVC every 2 weeks for a total duration of 8 weeks. The FOLFOX regimen consists of oxaliplatin (85 mg/m²) and leucovorin (400 mg/m²), each administered as a 2-hour intravenous infusion, and fluorouracil (2400 mg/m²) administered as a 44-hour continuous intravenous infusion. For patients with CRLM, targeted therapy will be selected according to RAS/BRAF status and primary tumor side. Cetuximab will be administered by intravenous injection for the treatment of RAS/BRAF wild-type left-sided CRLM. Bevacizumab will be administered by intravenous injection for the treatment of RAS/BRAF wild-type right-sided CRLM and RAS/BRAF mutant CRLM irrespective of primary tumor location.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
Junpeng Wang, Yan Sun, Longchang Chen et al. · BMJ Open · Sep 11, 2026 · PMID 42731846 pubmed
- DERIVEDWang J, Sun Y, Chen L, Wang Z, Li K, Guo Y, Yao L, Duan L, Liu Q. FOLFOX-based transarterial infusion chemotherapy for unresectable colorectal cancer: protocol of an open-label, multicentre, randomised, controlled, phase II trial. BMJ Open. 2026 Sep 11;16(9):e119746. doi: 10.1136/bmjopen-2026-119746. PMID 42731846