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

U

University of Chinese Academy Sciences

Status and phase

Unknown
Phase 2

Conditions

Carcinoma, Hepatocellular

Treatments

Drug: Anlotinib Hydrochloride
Device: TACE

Study type

Interventional

Funder types

Other

Identifiers

NCT04066543
ALTNZJ-002

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

TACE group
Active Comparator group
Description:
Device: Transcatheter arterial chemoembolization(TACE)
Treatment:
Device: TACE
TACE+Anlotinib group
Experimental group
Description:
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.
Treatment:
Device: TACE
Drug: Anlotinib Hydrochloride

Trial contacts and locations

1

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Central trial contact

Guoliang Shao

Data sourced from clinicaltrials.gov

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