TACE Plus Axitinib and Hydroxychlorquine for Liver-Dominant Metastatic Colorectal Cancer (CRC) — TACE-Ax-HCQ  

Colorectal Neoplasms Malignant Clinical Trial

Official title: Phase 1B Study of Hepatic Chemoembolization Plus Axitinib and Hydroxychlorquine for Liver-Dominant Metastatic Adenocarcinoma Of The Colon And Rectum

Status Terminated

Clinical Trial Summary

Liver metastases are a leading cause of death among patients with metastatic colorectal cancer. Duration of disease control is short following 2nd-line or later systemic therapy. Liver-directed therapy such as TACE has a higher response rate and improves progression-free survival (PFS), but the benefit is still limited. Cancer cells escape ischemic cell death via autophagy and hypoxia-inducible factor (HIF) activation. We hypothesize that blocking autophagy and the vascular endothelial growth factor (VEGF) pathway will improve both response and PFS following TACE.

Clinical Trial Description

Subjects with liver-dominant colorectal cancer metastases failing at least one line of systemic therapy will receive 2 weeks of axitinib 5mg twice daily (BID) and HCQ 600 mg BID followed by lobar or segmental TACE monthly until the entire tumor burden is treated, then continue axitinib/HCQ until progression or intolerable toxicity. Response and hepatic progression-free survival (HPFS) will be assessed one month post-TACE, then every 3 months. ;

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Colorectal Neoplasms Malignant
• Neoplasms

• NCT number: NCT04873895
• Study type: Interventional
• Source: Abramson Cancer Center at Penn Medicine
• Status: Terminated
• Phase: Phase 1
• Start date: January 24, 2022
• Completion date: April 25, 2024