NCT07333053Recruiting
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 · Last updated 11 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 18 Dec 2025
- Start date
- Mar 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Diseases
- Colorectal cancer
- NCT number
- NCT07333053
What you commit to
- Study type: Interventional
- Planned participants: 50
- From Mar 2026 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving other antitumor therapies, such as chemotherapy, targeted therapy or radiotherapy;
Other illness
- Patients have other primary malignant tumors;
- CRC patients with gastrointestinal perforation
- Patients with malignant bowel obstruction refractory to conservative management;
- Patients are allergic to the antitumor agents;
Other
- Patients with recurrent CRC;
- Patients with distant metastases besides synchronous hepatic metastases (e.g., pulmonary, bone, or brain metastases);
- For patients with CRLM, the MDT consensus recommends a liver-first treatment strategy to avoid the risk of rapid hepatic lesion progression;
- Women pregnant, breastfeeding or planning to become pregnant;
- Patients with MSI-H/dMMR CRC.
Who the study is looking for
- Age ≥ 18 years old;
- Histopathologically confirmed CRC adenocarcinoma;
- Locally advanced CRC confirmed as clinical T4 stage on CT/MRI imaging, with or without synchronous liver metastases;
- 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.
- No prior administration of chemotherapy, targeted therapy or radiotherapy for the current malignancy;
- 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;
- Estimated survival is more than 3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;
- All the patients in this study are required to sign an informed consent form.
Criteria the registry did not label
- Study population:
- Patients who meet all inclusion criteria and none of the exclusion criteria are eligible for enrolment and study treatment.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guang'anmen Hospital, China Academy of Chinese Medical Sciences Coordinator of this site? Confirm its status | Xicheng | China | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.