The Study of Apatinib Plus Radiotherapy vs. Apatinib in the Treatment of Hepatocellular Carcinoma With BCLC-C Stage I and Stage II Portal Vein Tumor Thrombus

Sponsor
Guangxi Medical University
Study ID
NCT03520257
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    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, double-blind, 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 also showed good efficacy and safety.
  • Radiotherapy — DEVICE
    Radiotherapy of tumors and portal vein tumor thrombi can promote further tumor shrinkage, and at the same time, the physiological basis for the recanalization of the original tumor thrombus itself will result in necrosis and fibrosis of the tumor thrombus, completely blocking the blood supply to the tumor portal vein. As a result, blood supply to the other side of the portal vein increases, and hepatocyte regeneration in a healthy liver is promoted, so that the patient can obtain surgical opportunities.

Study Details

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 anti-tumor 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. Radiotherapy of tumors and portal vein tumor thrombi can promote further tumor shrinkage, and at the same time, the physiological basis for the recanalization of the original tumor thrombus itself will result in necrosis and fibrosis of the tumor thrombus, completely blocking the blood supply to the tumor portal vein. As a result, blood supply to the other side of the portal vein increases, and hepatocyte regeneration in a healthy liver is promoted, so that the patient can obtain surgical opportunities. Based on the therapeutic potential of apatinib and radiotherapy, we designed a prospective exploratory clinical study of this patient with advanced liver cancer.

Key Dates

Start date
May 1, 2018
Status verified
Apr 2018
Primary completion
Dec 31, 2018
Completion
Jun 30, 2019

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib Plus Radiotherapy
  • Other: Apatinib

Primary Outcome Measure

overall survival [ Time Frame: 5 years ]

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