NCT06423937

Fruquintinib Plus Camrelizumab and HAIC in the Treatment of Non-MSI-H Advanced Colorectal Cancer

A Single-center, Open-label, Double-cohort Clinical Study of Fruquintinib Plus Camrelizumab Plus HAIC in the Treatment of Non-MSI-H Advanced Colorectal Cancer Patients With Liver Metastasis After the Failure of First-line Treatment

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Liver metastasis is the main cause of death in patients with colorectal cancer. The treatment of liver metastasis of colorectal cancer is the key to prolong the survival of patients. The purpose of this study was to investigate the efficacy and safety of fruquintinib combined with Camrelizumab and HAIC regimen in the treatment of non-MSI-H advanced colorectal cancer patients with liver metastasis after first-line standard treatment failure. Compared with the current standard second-line treatment plan, it provides new decisions for clinical practice, in order to reduce the adverse reactions of treatment and improve the tolerance and efficacy of patients. To provide more and more optimized medication options for patients with non-MSI-H advanced colorectal cancer complicated with liver metastasis.

Detailed description

This is a single-center, open, double-cohort clinical study to explore the non-MSI-H type advanced colorectal cancer patients with liver metastases after the failure of first-line standard treatment with fruquintinib combined with calelizumab and HAIC.Clinically, systemic chemotherapy with 5-FU as the core, combined with irinotecan or oxaliplatin is the first-line and second-line standard chemotherapy regimen for unresectable CRLM patients, but various hepatotoxicity will occur during chemotherapy. HAIC can selectively deliver chemotherapeutic drugs to tumor cells, reduce hepatocyte toxicity, relatively preserve liver parenchyma, and increase the concentration of chemotherapy in the tumor. Tumor cells are exposed to chemotherapy for a longer time, which effectively improves the efficacy and safety of treatment. Anti-angiogenic drugs can hinder the growth of microvessels in tumors and the development of metastatic diseases. At present, multiple retrospective studies have provided evidence support. The response rate of HAIC combined with systemic targeted therapy can reach 74 % -92 %. Previous studies have suggested that anti-angiogenic drugs combined with immunotherapy is expected to be a treatment strategy for patients with advanced colorectal cancer who fail to receive standard treatment or cannot receive standard treatment. Therefore, this study investigated the efficacy and safety of fruquintinib combined with Camrelizumab and HAIC in the treatment of patients with non-MSI-H advanced colorectal cancer complicated with liver metastasis after first-line standard treatment failure.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	combination therapy Combination: Fruquintinib plus Camrelizumab and HAIC (TOMOX/TOMIRI) Maintenance: Fruquintinib plus Camrelizumab	Procedure/Surgery: HAIC After successful percutaneous hepatic artery cannulation, superior mesenteric arteriogram and hepatic arteriogram were performed, and after confirming that the subjects were eligible for enrollment according to the results, the hepatic artery was cannulated to the predetermined position. The catheter was connected to a syringe pump in the ward for continuous pumping of drugs. TOMOX（Raltitrexed 2 mg/m2, Oxaliplatin 85mg/m2）/ TOMIRI（Raltitrexed 2 mg/m2 ，Irinotecan 120mg/m2） Drug: Fruquintinib 3mg, qd, po, 21 days for a cycle, Suspend medication on the day of HAIC Drug: Camrelizumab 200mg, ivgtt,, 21 days for a cycle

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2024-05-21
• Last updated: 2024-05-21

Locations

1 site across 1 country: China