Liquid Biopsy in Hepatocellular Carcinoma

Hepatic Carcinoma Malignant Primary Non-Resectable Clinical Trial

— HCCGenePanel  

Official title:

Assessment of Response to Locoregional Therapy Using Liquid Biopsy in Patients With Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04111029
• Other study ID #: INT/HEP/1078
• Status: Recruiting
• Start date: January 16, 2020
• Est. completion date: March 2024

Study information

• Verified date: April 2023
• Source: Postgraduate Institute of Medical Education and Research
• Contact: Madhumita Premkumar, MD DM
• Phone: 01722754777
• Email: drmadhumitap[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Circulating tumor DNA (ctDNA) carrying tumor-specific sequence alterations has been found in the cell-free fraction of blood. Hepatocellular carcinoma (HCC) specimens are difficult to obtain, and noninvasive methods are required to assess cancer progression and characterize underlying genomic features. Use of 'liquid biopsy' by assessing circulating cell free DNA enables the clinician to offer targeted immunotherapy or signaling pathway inhibitors. It also offers a model to prove response to locoregional or immunotherapy therapy and predict tumor recurrence non-invasively.

Description:

Novelty:

Mutation analysis may not only help identify cancer drivers, but they can also provide useful data to predict response to other treatment modalities such as immunotherapies, particularly immune checkpoint blockade. There is published data on liquid biopsy in India from oncology in the field of pulmonary and renal cancers, but these studies have not been done in cirrhosis or in HCC patients.

Objectives In this project we hope to develop a biomarker panel which helps us prognosticate patients and tailor targeted therapy as per their genetic mutation landscape. The treatment options for advanced HCC are limited, and tissue biopsy is not routinely performed.

Methods In this pilot project, we will analyze 30 patients with unresectable hepatocellular carcinoma, ineligible for liver transplantation, who will undergo locoregional therapy in the form of transarterial chemoembolization (TACE) or radioembolization (TARE) for tissue diagnosis of tumor tissue DNA and circulating tumor DNA. We will design personalized assays targeting somatic rearrangements of each tumor to quantify serum ctDNA. Exome sequencing will be performed using cell-free DNA and paired primary tumor tissue DNA in order to create a non-invasive liquid biopsy for diagnosis and prognostication of HCC.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2024
• Est. primary completion date: December 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Hepatocellular carcinoma BCLC stages B and C of all aetiology, unresectable

• Age 18-70 years of either sex

Exclusion Criteria:

• Contemplating Hepatic resection or OLT

• Refractory ascites

• Severe Coagulation disorders prior to the procedure (PTI <70% and Platelet count < 80,000/mm3)

• Hepato-Renal syndrome

• Chronic Kidney Disease

• Acute decompensation like Hepatic encephalopathy and variceal bleeding

• Any known malignancy other than HCC

• Life expectancy < 6 months

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatic Carcinoma Malignant Primary Non-Resectable

Intervention

Diagnostic Test:
• Cell Free DNA
Pre and post procedure plasma cell free DNA will be assessed for response to locoregional therapy

Locations

Country	Name	City	State
India	Postgraduate Institute of Medical Education and Research	Chandigarh	Choose Any State/Province

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of exome sequencing of primary tumor tissue and cell-free DNA from plasma samples		0, 90 days
Primary	Serial Quantification of ctDNA in plasma samples by means of real-time PCR post treatment		90 days
Secondary	Time to first recurrence (local or distant) diagnosed on follow up dynamic imaging.		90 days
Secondary	Mortality		90 days