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Cola

2 weeks of axitinib 5mg BID and hydroxychloroquine 600 mg BID followed by lobar or segmental trans arterial chemoembolization monthly until the entire tumor burden is treated, then continue axitinib/HCQ until progression or intolerable toxicity.

axitinib 5 mg po BID until progression or intolerance

Axitinib 5 MG

hydroxychloroquine 600 mg po BID until progression or intolerance

Hydroxychloroquine Pill

segmental or lobar TACE at 4-8 week intervals until entire tummy burden is treated.

trans arterial chemoembolization

Michael C Soulen, MD

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.

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.

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

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

SAE is scored by CTCAE v5 (G3 or higher) and the 2017 revision of the Society of Interventional Radiology (SIR) Complications Classification categories 3-5.

complete and partial response rate by RECIST and modified RECIST

Time from initiation of therapy to progression in the liver by RECIST, death from any cause, or last documented progression-free status.

Time from initiation of therapy to progression anywhere by RECIST, death from any cause, or last documented progression-free status.

Time from initiation of therapy to death or last follow-up alive

Weeks on axitinib therapy multiplied by percentage of initially prescribed dose

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
TACE Plus Axitinib and Hydroxychlorquine for Liver-Dominant Metastatic Colorectal Cancer (CRC)	NCT04873895	Colorectal Neop...	Axitinib 5 MG Hydroxychloroqu... trans arterial ...	18 Years -	Abramson Cancer Center at Penn Medicine
TACE Plus Axitinib and Hydroxychlorquine for Liver-Dominant Metastatic Colorectal Cancer (CRC)	NCT04873895	Colorectal Neop...	Axitinib 5 MG Hydroxychloroqu... trans arterial ...	18 Years -	Abramson Cancer Center at Penn Medicine

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