This is an open-label, single site, Phase IIA clinical trial to investigate the safety and efficacy of an individualized anti-cancer vaccine (CRCL-AlloVax) in advanced HCC patients.
Hepatocellular carcinoma (HCC) or primary liver cancer is the third leading cause of cancer death worldwide. It accounts for 90% of all liver cancers. More than 80% of patients present with advanced or unresectable disease. For patients with vascular invasion and/or metastases, the only approved therapy that offers a survival advantage is Sorafenib (Nexavar®). While palliative systemic chemotherapy other than Sorafenib is sometimes offered for HCC, there is no evidence that any chemotherapy has any meaningful therapeutic benefit, especially in overall survival. Subjects in the current study will either have completed at least 90 days of sorafenib treatment or are not able to receive sorafenib due to intolerability or unable to afford. Subjects will continue sorafenib as tolerated while receiving experimental therapy. The experimental dosing schedule has four segments: (1) priming, which consists of intradermal AlloStim alone; (2) vaccination, which consists of intradermal dosing of AlloStim+CRCL; (3) activation, which consists of an intravenous infusion of AlloStim; and (4) booster, which consists of monthly intradermal injections of CRCL alone
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
National Cancer Institute of Thailand Address: 268/1 Rama Rd. Ratchathewi
Bangkok, Thailand
To evaluate survival compared to historical controls
Baseline to date of death from any cause
Time frame: Approximately 12 months
To assess AFP as surrogate end-point for response and/or survival
Biomarker concentration will be evaluated at different time points
Time frame: Approximately 6 months
To assess mRECIST as surrogate end-point for response and/or survival
Objective tumor responses by mRECIST will be compared with OS
Time frame: Approximately 6 months
To evaluate safety in advanced HCC (adverse events)
Subjects will be followed by physical exam, blood labs, CT scan and biopsy for any adverse events
Time frame: Approximately 6 months
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