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

Sponsor
Zhejiang Cancer Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04066543
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
26
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: TACE
  • Drug: Anlotinib Hydrochloride
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
TACE vs.TACE+AnlotinibTACE vs.TACE+Anlotinib
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-center Randomized Controlled Clinical Trial of TACE Combined With Anlotinib Comparing With TACE in the Treatment of Middle-advanced Hepatocellular Carcinoma (HCC) Patients
Anticipated Study Start Date :
Aug 30, 2019
Anticipated Primary Completion Date :
May 30, 2021
Anticipated Study Completion Date :
Oct 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: TACE group

Device: Transcatheter arterial chemoembolization(TACE)

Device: TACE
The modified Seldinger puncture was used to puncture the cutaneous-femoral artery, insert the catheter and perform hepatic artery angiography. The location, morphology and blood supply of liver tissue lesions were comprehensively understood. The use of chemotherapeutic drugs and the dosage of iodized oil as the embolic agent were determined according to the general situation. The catheter was injected into the supply vessel of the tumor, and 5-FU and adriamycin were injected according to the situation. The embolic agent was injected with iodized oil as carrier, mixed with chemotherapeutic drugs at the same time, and then assisted with gelatin sponge for embolization. Antiemetic drugs were given before treatment and hepatoprotective drugs were given after operation. Until the disease progresses.
Experimental: TACE+Anlotinib group

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.

Device: TACE
The modified Seldinger puncture was used to puncture the cutaneous-femoral artery, insert the catheter and perform hepatic artery angiography. The location, morphology and blood supply of liver tissue lesions were comprehensively understood. The use of chemotherapeutic drugs and the dosage of iodized oil as the embolic agent were determined according to the general situation. The catheter was injected into the supply vessel of the tumor, and 5-FU and adriamycin were injected according to the situation. The embolic agent was injected with iodized oil as carrier, mixed with chemotherapeutic drugs at the same time, and then assisted with gelatin sponge for embolization. Antiemetic drugs were given before treatment and hepatoprotective drugs were given after operation. Until the disease progresses.

Drug: Anlotinib Hydrochloride
Anlotinib hydrochloride capsule, according to the recommended dose, po, qd, continuous oral 2 weeks stop for 1 week, 3 weeks for a cycle.
Other Names:
  • Anlotinib

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PFS [12 months]

      Progress Free Survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhejiang Cancer Hospital Hangzhou Zhejiang China

    Sponsors and Collaborators

    • Zhejiang Cancer Hospital

    Investigators

    • Principal Investigator: Guoliang Shao, Zhejiang Cancer Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhejiang Cancer Hospital
    ClinicalTrials.gov Identifier:
    NCT04066543
    Other Study ID Numbers:
    • ALTNZJ-002
    First Posted:
    Aug 26, 2019
    Last Update Posted:
    Aug 26, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of Aug 26, 2019