NCT03511703

The Study of The Treatment of Postoperative Adjuvant Apatinib vs. TACE in Hepatocellular Carcinoma Patients

A Randomized Clinical Study of The Treatment of Postoperative Adjuvant Apatinib vs. TACE in Hepatocellular Carcinoma Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Guangxi Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study uses to suppress the growth of tumors, extend the patient's survival time and improve the quality of life as much as possible. Through the treatment, the patient is given the chance to undergo surgical resection, thereby more effectively prolonging the OS. Apatinib is a small-molecule VEGFR tyrosine kinase inhibitor. It mainly treats malignant tumors by inhibiting VEGFR and exerting anti-angiogenic effects. Preclinical studies have shown that its antitumor effect is better than that of the similar drug PTK787. Phase II studies of hepatocellular carcinoma have initially demonstrated the effectiveness and safety of apatinib in the treatment of advanced HCC. TACE embolized tumor artery blood supply to inhibit tumor growth and shrink tumors. Based on the therapeutic potential of apatinib, and TACE in their respective tumors, we designed a prospective exploratory clinical study of this patient with advanced liver cancer.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Apatinib	Apatinib, a small molecule anti-angiogenic targeted drug that has been demonstrated to be safe and effective after failure of standard chemotherapy for advanced gastric cancer, has been initially successful in phase II clinical trials for the treatment of unresectable advanced HCC patients. The efficacy of ralfiny in the treatment of Oriental population (ORIENTAL study) is better. The randomized, doubleblind, multi-center phase III clinical study of apatinib second-line treatment of advanced hepatocellular carcinoma showed a good efficacy and safety. Currently, Phase III clinical studies of apatinib in HCC patients undergoing systemic chemotherapy or sorafenib treatment have progressed. Initial results lso showed good efficacy and safety.
DRUG	Chemotherapy drugs+Iodized oil	Intra-arterial infusion chemotherapy for tumors, commonly used chemotherapy drugs include anthracyclines, platinum, etc.; chemotherapeutic drugs and embolic agents are mixed together and injected through the blood supply artery of the tumor. The most commonly used embolic agent for TACE treatment is a lipiodol emulsion. First infusion of some chemotherapy drugs, the general infusion time should not be \<20 min. Then another part of the chemotherapeutic drugs and lipiodol were mixed into emulsions for embolization. The amount of lipiodol is generally 5-20 ml, not more than 30 ml.

Timeline

• Start date: 2018-05-01
• Primary completion: 2018-12-31
• Completion: 2019-06-30
• First posted: 2018-04-30
• Last updated: 2018-04-30