A Phase II Clinical Trial on the Combination Therapy of PHY906 Plus Capecitabine in Hepatocellular Carcinoma
Chun A Changou 1 2 3 , Her-Shyong Shiah 1 , Li-Tzong Chen 4 , Servina Liu 5 , Frank Luh 5 , Shwu-Huey Liu 6 , Yung-Chi Cheng 7 , Yun Yen 1
Affiliations
Affiliations
1
The PhD Program for Cancer Molecular Biology and Drug Discovery, Taipei Medical University, Taipei, Taiwan.
2
The PhD Program for Translational Medicine, College of Medical Science and Technology, Taipei Medical University, Taipei, Taiwan.
3
The Core Facility Center, Office of Research and Development, Taipei Medical University, Taipei, Taiwan.
4
National Health Research Institutes, Tainan, Taiwan.
5
Sino-American Cancer Foundation, Covina, California, USA.
6
Yiviva Inc., New York, New York, USA.
7
Yale University School of Medicine, New Haven, Connecticut, USA.
PMID: 33140457 DOI: 10.1002/onco.13582
Abstract
Lessons learned: A PHY906 and capecitabine combination could be effective as a salvage therapy for patients with hepatocellular carcinoma (HCC) previously treated with multiple systemic therapies. This traditional Chinese medicine formulation can work with Western cancer chemotherapeutic agents to improve clinical outcomes or alleviate side effects for patients with advanced HCC.
Background: This study aimed to evaluate efficacy and safety of capecitabine combined with a PHY906 (a pharmaceutical-grade formulation of four traditional Chinese herbs) in the treatment of advanced hepatocellular carcinoma (HCC) in Asian patients who were positive for hepatitis B virus (HBV).
Methods: This study was an open-label, phase II safety and efficacy clinical trial of PHY906 and capecitabine in patients with advanced HCC. Patients received 750 mg/m2 capecitabine b.i.d. 14 days plus 800 mg of PHY906 b.i.d. on days 1-4 and days 8-11 every 21-day cycle. The primary endpoint was 6-month survival rate, and secondary endpoints were progression-free survival, overall survival, disease control rate, and safety.
Results: Thirty-nine subjects completed the study with a 46.2% stable disease rate. The median progression-free survival was 1.5 months, and median overall survival (mOS) was 6 months with a 51.3% 6-month survival rate. The most common adverse events included lower hemoglobin, diarrhea, pain, abdomen NOS, fatigue, increased AST, and bilirubin. Patients who (a) had not received previous chemotherapies or targeted therapy or (b) had lower starting alpha-fetoprotein (AFP) levels or (c) had HBV infection showed better clinical outcome.
Conclusion: Our data showed that PHY906 increases the therapeutic index of capecitabine by enhancing its antitumor activity and reduces its toxicity profile in advanced HCC.
PHY906联合卡培他滨联合治疗肝癌的Ⅱ期临床试验
Chun A Changou 1 2 3，Shi-Shyong Shiah 1，Chen Li-Tzong 4，Servina Liu 5，Frank Luh 5，Liu Shhu-Huey Liu 6，Cheng Yung-Chi 7，Yun Yen 1
隶属关系
隶属关系