Hepatocellular Carcinoma Using Stereotactic Body Radiotherapy

Status Active, not recruiting

Clinical Trial Summary

Respiratory-gated, volumetric-modulated arc therapy will be used for the clinical development of high dose rate Stereotactic Body Radiotherapy (SBRT) in inoperable hepatocellular carcinoma (HCC). These treatments should enhance local control, progression-free survival and potentially overall survival in HCC patients. The investigators will also examine the mechanism of tumour and microenvironmental response to high dose radiation, and search for potential biomarkers to optimize and individualize therapy. Pre-treatment and follow-up PET/CT imaging with 11C-choline, 18F-fluorodeoxyglucose (FDG) and CT perfusion will examine in-vivo changes in proliferation, glycolysis, and the tumour vasculature, respectively, and blood samples will look for immunologic biomarkers of tumour response.

Clinical Trial Description

Radiotherapy is not considered standard of care practice for patients for inoperable hepatocellular carcinoma despite the tumour's inherent radiosensitivity. The major challenge has been improving radiation delivery without exceeding dose limits of the surrounding normal liver. Recent technological advances with tumour localization and targeting, imaging, treatment planning and delivery have allowed for safe delivery of radiation with tumorcidal effect and minimal treatment-related toxicity.

This study has three specific aims:

1. To develop, validate, and quality test HDR Stereotactic Body Radiotherapy (SBRT) Gated RapidArc technique for application in human liver tumours. And furthermore, to test whether HDR SBRT Gated RapidArc can be efficiently and safely delivered to a very large patient population previously ineligible for any therapy (HCC patients with tumours >5cm).

3. To determine if 11C-choline/18F-FDG CT-PET or perfusion CT imaging (that characterize changes in tumour proliferation, glycolysis, and vasculature, respectively) can provide practical non-invasive biomarkers of tumour response, local tumour control, or normal tissue toxicity.

4. To determine if immunologic studies of pre- and post-treatment blood samples can provide biomarkers of tumour response, local and systemic tumour control, or triggers for normal tissue toxicity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01850316
Study type	Interventional
Source	British Columbia Cancer Agency
Contact
Status	Active, not recruiting
Phase	N/A
Start date	July 2013
Completion date	August 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04209491` - Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway
Completed	`NCT03963206` - Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE)	Phase 4
Completed	`NCT03268499` - TACE Emulsion Versus Suspension	Phase 2
Recruiting	`NCT05263830` - Glypican-3 as a Prognostic Factor in Patients With Hepatocellular Carcinoma Treated by Immunotherapy
Recruiting	`NCT05044676` - Immune Cells as a New Biomarker of Response in Patients Treated by Immunotherapy for Advanced Hepatocellular Carcinoma
Recruiting	`NCT05095519` - Hepatocellular Carcinoma Imaging Using PSMA PET/CT	Phase 2
Recruiting	`NCT05497531` - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers	N/A
Completed	`NCT05068193` - A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers	Phase 1
Active, not recruiting	`NCT03781934` - A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations	Phase 1/Phase 2
Terminated	`NCT03655613` - APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC	Phase 1/Phase 2
Active, not recruiting	`NCT03170960` - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors	Phase 1/Phase 2
Active, not recruiting	`NCT04242199` - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors	Phase 1
Completed	`NCT04401800` - Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma	Phase 2
Withdrawn	`NCT05418387` - A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona	N/A
Active, not recruiting	`NCT04039607` - A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma	Phase 3
Terminated	`NCT03970616` - A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma	Phase 1/Phase 2
Recruiting	`NCT03642561` - Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE	Phase 2/Phase 3
Recruiting	`NCT04118114` - Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors	Phase 2
Recruiting	`NCT06239155` - A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors	Phase 1/Phase 2
Completed	`NCT03222076` - Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer	Phase 2