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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

NCT03520257 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-05-09

No results posted yet for this study

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 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.

Conditions

Interventions

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, 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.

DEVICE

Radiotherapy

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.

Sponsors & Collaborators

  • Guangxi Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2018-12-31
Completion
2019-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03520257 on ClinicalTrials.gov