NCT03114085

Apatinib Combined With Capecitabine Compared With Apatinib Treat Advanced Hepatocellular Carcinoma

Apatinib Combined With Capecitabine Compared With Apatinib in the Treatment of Advanced Non-resectable Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: First Affiliated Hospital of Guangxi Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

It is an open,randomized,controlled study, and the purpose of this study is to observe and evaluate the efficacy and safety of Apatinib combined with Capecitabine in the treatment of patients with advanced hepatocellular carcinoma.

Detailed description

This study is the clinical study of Apatinib combined with Capecitabine compared with Apatinib in the treatment of advanced non-resectable Hepatocellular Carcinoma, the object is patients with advanced hepatocellular carcinoma,its purpose is to observe and evaluate the efficacy and safety of Apatinib Mesylate Tablets combined with Capecitabine in the treatment of patients with advanced hepatocellular carcinoma, its main primary endpoint is TTP (time to progression) while the secondary endpoint is OS (overall survival), ORR (objective response rate), DCR (disease control rate), serum alpha-fetoprotein (AFP) levels and quality of life. 170 patients will be enrolled and 1:1 randomized into two groups: Apatinib combined Capecitabine and Apatinib alone. Major safety indicators are Vital signs, laboratory indicators, adverse events (AE), serious adverse events (SAE), drug-related AE and SAE, and specific AE (such as hypertension, proteinuria, and hand-foot syndrome), according to NCI-CTCAE.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Capecitabine	Capecitabine 1000mg/m2 po bid, d1-d14, every 21 days for a cycle;
DRUG	Apatinib	Apatinib 500 mg po qd, d1-d21, every 21 days for one cycle

Timeline

• Start date: 2017-05-20
• Primary completion: 2019-03-20
• Completion: 2019-05-20
• First posted: 2017-04-14
• Last updated: 2017-05-15