Treatment Patients With Pulmonary Metastasis of Liver Cancer With Apatinib Combination With TACE: a Clinical Study

University of Chinese Academy Sciences

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Pulmonary Metastasis; Hepatocellular Carcinoma

Treatments: Procedure: TACE; Drug: Apatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT02702323

Ahead-H302

Details and patient eligibility

About

This study mainly evaluate the clinical effect of Apatinib in the treatment of patients with pulmonary metastasis of hepatocellular carcinoma.Half of participants will receive Apatinib and transcatheter arterial chemoembolization (TACE) therapy in combination,while the other half will receive TACE therapy alone.

Full description

Apatinib is a VEGFR targeting tyrosine kinase inhibitor, which has preliminary demonstrated the efficacy and safety in treatment of advanced hepatocellular carcinoma by phase II stage research. Pulmonary metastasis of hepatocellular cancer is one of the difficulties in clinical practice,because it's not sensitive to systemic chemotherapy.This phase Ⅲ study aims to evaluates the efficacy and safety of the Apatinib in the treatment of advanced hepatocellular cancer with pulmonary metastasis.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinical diagnosis of hepatocellular carcinoma
• refused to sorafenib treatment
• have at least one measurable pulmonary lesions
• expected survival time ≥ 12 weeks

Exclusion criteria

• within four weeks before the study received radiotherapy or chemotherapy
• With a variety of factors influencing oral drugs taking and absorption (such as unable to swallow, chronic diarrhea and intestinal obstruction)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Apatinib & TACE

Experimental group

Description:

Apatinib 500mg tablet by mouth per day, until disease progression, combined with TACE therapy one times every 4-6 weeks.

Treatment:

Drug: Apatinib

Procedure: TACE

TACE

Active Comparator group

Description:

TACE therapy one times every 4-6 weeks.

Treatment:

Procedure: TACE