TACE Combined With Anlotinib Treatment of Middle-advanced Hepatocellular Carcinoma (HCC) Patients

Phase 2

• Conditions: Carcinoma, Hepatocellular
• Interventions: Device: TACE; Drug: Anlotinib Hydrochloride

• Registration Number: NCT04066543
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

This study was designed to evaluate the effectiveness of Anlotinib in middle-advanced Hepatocellular Carcinoma (HCC) Patients.

Detailed Description

The aim of this study is to include 40 patients with middle-advanced Hepatocellular Carcinoma .These patients were randomly allocated to TACE treatment group or TACE+Anlotinib treatment group.The treatment effectiveness, local tumor control and survival outcome between the two groups were compared.

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-08-22
• Last Update Submitted: 2019-08-22
• Study First Posted: 2019-08-26
• Last Update Posted: 2019-08-26
• Study Start: 2019-08-30
• Primary Completion: 2021-05-30
• Study Completion: 2021-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Subject has no contraindication to chemotherapy, and has no obvious obstacles in the function of major organs such as heart, lung, liver and kidney;
2. Subject has middle-advanced liver cancer of Barcelona Clinic Liver Cancer stages B/C ;
3. Liver function child-pugh class A or B; Karnofsky (KPS) score > 60 points;
4. Subject could not accept surgical resection or refuse surgical operation;and who did not receive other treatment before operation.

5.18~75 years old; ECOG PS score: 0-1 points; expected survival period is more than 3 months.

Exclusion Criteria

1. Subject has contraindications to chemotherapy;
2. Subject has obstacle in the function of major organs such as heart, lung, liver and kidney;
3. Severe coagulation dysfunction (prothrombin time > 18 s or hemorrhagic tendency);
4. Uncontrollable hypertension and portal hypertension;
5. Hepatic artery-portal vein or hepatic vein fistula or portal vein trunk cancer thrombus;
6. A large amount of ascites or refractory ascites;
7. With distant metastasis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TACE group	TACE	Device: Transcatheter arterial chemoembolization(TACE)
TACE+Anlotinib group	TACE	Device: Transcatheter arterial chemoembolization Drug: Anlotinib Anlotinib hydrochloride capsule, according to the recommended dose, po, qd, continuous oral 2 weeks stop for 1 week, 3 weeks for a cycle.
TACE+Anlotinib group	Anlotinib Hydrochloride	Device: Transcatheter arterial chemoembolization Drug: Anlotinib Anlotinib hydrochloride capsule, according to the recommended dose, po, qd, continuous oral 2 weeks stop for 1 week, 3 weeks for a cycle.

Primary Outcome Measures

Name	Time	Method
PFS	12 months	Progress Free Survival

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China