Clinical Efficacy of Transarterial Infusion Chemotherapy for Unresectable Colorectal Cancer

Summary

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).

Eligibility

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.

Conditions2

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