Liquid Biopsy in Hepatocellular Carcinoma (HCCGenePanel)

Post Graduate Institute of Medical Education and Research, Chandigarh

Status: Enrolling

Conditions: Hepatic Carcinoma Malignant Primary Non-Resectable

Treatments: Diagnostic Test: Cell Free DNA

Study type: Observational

Funder types: Other

Identifiers

NCT04111029

INT/HEP/1078

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Unresectable HCC undergoing locoregional therapy

Description:

Patients with unresectable HCC who have no curative option like tumour ablation, resection or transplantation and are being taken for locoregional therapy will be recruited

Treatment:

Diagnostic Test: Cell Free DNA