Hepatocellular Carcinoma, Liver Cancer
Conditions
Keywords
hepatocellular carcinoma, advanced, unresectable, liver cancer, systemic chemotherapy, botanical, herbal, alternative and complementary medicine, capecitabine, PHY906, oral, HCC, traditional chinese medicine, tcm, QOL, quality of life
Brief summary
Capecitabine is a chemotherapeutic that has been approved for use in breast and colorectal cancers. The advantages of capecitabine are that (1) it is an oral drug; and (2) it is less toxic than many other chemotherapeutics. In an off-label hepatocellular carcinoma (HCC) clinical study, the response rate with capecitabine was 13%. The botanical drug PHY906--currently manufactured pursuant to GMP standards and regulations--has been used in China for over 1800 years to treat gastrointestinal-related ailments. Recently, preclinical studies demonstrated that PHY906 potentiates the anti-tumor effect of capecitabine. This trial will evaluate the safety and efficacy of PHY906 in enhancing the anti-tumor effects of capecitabine.
Interventions
DRUGPHY906
DRUGcapecitabine
Sponsors
PhytoCeutica
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Men or women 18 to 80 years of age with a histologic or cytologic diagnosis of HCC or who meet all of the following criteria: (a) a-fetoprotein levels \> 600 ng/mL; and (b) presence of cirrhosis or chronic hepatitis B or C; and (c) characteristic enhancement pattern of liver tumors on triphasic CT scan or MRI. * All patients previously exposed to any prior anticancer treatments must have clear evidence of progressive disease after the most recent treatment regimen (see
Exclusion criteria
). * In the phase I (dose finding) and phase II (efficacy) portions of the study, patients may either have had no prior chemotherapy (chemotherapy naive), no prior capecitabine chemotherapy, or have been refractory to--or relapsed from--no more than two prior systemically administered treatment regimens. (Chemoembolization is not regarded in this context as a systemically administered treatment regimen.) * All patients in both the phase I and phase II portions of this study must have at least one previously unirradiated, bidimensionally measurable lesion by computerized tomography (CT) or magnetic resonance imaging (MRI) scan of \> 20 mm (if conventional CT scan) or more than or equal to 10 mm (if spiral CT scan). Triphasic spiral CT or MRI scans are preferred when such equipment is available. All CT scans should employ a hepatoma protocol image capture technique. * Patients with central nervous system (CNS) involvement will have had appropriate treatment and will be free of progressive neurological deficits in the 28 days prior to enrollment. * Patients with cirrhosis must have a Child-Pugh cirrhosis severity classification no greater than B. * Baseline performance status must be Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2. * Life expectancy must be reasonably estimated to be \> 12 weeks. * Women patients who are known to be capable of conception should have a negative serum pregnancy test (beta-human chorionic gonadotropin \[b-hCG\]) within 2 weeks of starting the study; all patients should agree to use adequate non-estrogenic birth control methods, consistent with the institute's standard form of contraception if conception is possible during the study. * Provide written informed consent prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor imaging and evaluation every 6 weeks | — |
| Alphafetoprotein measurements every 3 weeks for first 3 courses, then every 6 weeks thereafter | — |
Secondary
| Measure | Time frame |
|---|---|
| QoL assessment every 3 weeks | — |
| Survival follow-up every 2 months | — |
Countries
Taiwan, United States
Outcome results
None listed