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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

Pfizer

Abramson Cancer Center at Penn Medicine

Heart and Blood Diseases

Carcinoma

Carcinoma, Hepatocellular

Thrombosis

Venous Thrombosis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Liver Neoplasms

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Embolism and Thrombosis

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determine frequency of short-term mortality (\< 3month) among HCC patients with PPVT after TACE, and to explore its predictors.

trans arterial chemoembolization in patient with partial portal vein thrombosis

Hepatocellular carcinoma (HCC) is the fifth most common neoplasm worldwide and the third most frequent cause of death from cancer in the world. Hepatocellular carcinoma is responsible for significant morbidity and mortality in cirrhosis. Most cases of HCC occur in the setting of cirrhosis and, therefore, prognosis is determined not only by factors related to the tumor but also by factors related to cirrhosis (1).

According to previous reports, the incidence of HCC with partial portal vein thrombosis (PVTT) ranges between 44% and 62.2%. HCC associated with PVTT has a poor prognosis. It may lead to intrahepatic metastasis, liver dysfunction, and portal hypertension. The median overall survival for HCC patients with untreated PVTT is only 2.7 months (2).

It was suggested that HCC with PVTT should be classified as stage C based on Barcelona Clinic Liver Cancer; it is no longer surgically treatable. Compared with conservative treatment, TACE is a safe and effective therapy for such cases. However, this modality for treatment might be associated with mortality (3).

As far as we know, there is no studies of short-term survival in patients with HCC and PVT after TACE in our locality.

Our study aims to determine frequency of short-term mortality (\< 3month) among HCC patients with PPVT after TACE, and to explore its predictors.

Type of the study:cohort study Study Setting: Assiut University Hospitals

Sample Size Calculation:

Total coverage sample technique will be applied in the current study where all patients who are fulfilling inclusion criteria during the study period will be included.

Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ...):

For all the study patients, clinical evaluation (including demographic data and body mas index), laboratory investigations (including liver and kidney chemistry, INR, and complete blood picture), and imaging studies (including abdominal ultrasonography, doppler ultrasonography, and contrast computed tomography) will be provided.

CTP and MELD scores will be calculated.

Data management and analysis (Details needed):

Data collection: will include patients between 2015 and 2023. Computer software

Statistical tests:

Based on short term survival, eligible patients will be subdivided into two groups either survivors or non-survivors. Continuous data will be given in form of mean (SD) and compared by Student t test while nominal data will be expressed as frequency (percentage) and chi square test is used for such data.

Overall survival analysis will be done by Kaplan Meier survival curve. Logistic regression analysis will be applied to determine the possible predictors for short term mortality.

Level of confidence is kept at 95% and hence, p value is considered significant if \< 0.05. Analysis of data will be done by SPSS 28 software

Outcome of Hepatocellular Carcinoma Patients With Portal Vein Thrombosis After Trans-Arterial Chemo Embolization

all researcher will be blinded about data collection from other researchers.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Outcome of Hepatocellular Carcinoma Patients With Portal Vein Thrombosis After Trans-Arterial Chemo Embolization	NCT05491889	Hepatocellular ...	trans arterial ...	18 Years -	Assiut University
Outcome of Hepatocellular Carcinoma Patients With Portal Vein Thrombosis After Trans-Arterial Chemo Embolization	NCT05491889	Hepatocellular ...	trans arterial ...	18 Years -	Assiut University

Spots Global Cancer Trial Database for trans arterial chemoembolization