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

Primary Purpose

Carcinoma, Hepatocellular

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TACE
Anlotinib Hydrochloride
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

TACE group

TACE+Anlotinib group

Arm Description

Device: Transcatheter arterial chemoembolization(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.

Outcomes

Primary Outcome Measures

PFS
Progress Free Survival

Secondary Outcome Measures

Full Information

First Posted
August 22, 2019
Last Updated
August 22, 2019
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04066543
Brief Title
TACE Combined With Anlotinib Treatment of Middle-advanced Hepatocellular Carcinoma (HCC) Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2019 (Anticipated)
Primary Completion Date
May 30, 2021 (Anticipated)
Study Completion Date
October 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
TACE vs.TACE+Anlotinib
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TACE group
Arm Type
Active Comparator
Arm Description
Device: Transcatheter arterial chemoembolization(TACE)
Arm Title
TACE+Anlotinib group
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
TACE
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Anlotinib Hydrochloride
Other Intervention Name(s)
Anlotinib
Intervention Description
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 Measure Information:
Title
PFS
Description
Progress Free Survival
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has no contraindication to chemotherapy, and has no obvious obstacles in the function of major organs such as heart, lung, liver and kidney; Subject has middle-advanced liver cancer of Barcelona Clinic Liver Cancer stages B/C ; Liver function child-pugh class A or B; Karnofsky (KPS) score > 60 points; 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: Subject has contraindications to chemotherapy; Subject has obstacle in the function of major organs such as heart, lung, liver and kidney; Severe coagulation dysfunction (prothrombin time > 18 s or hemorrhagic tendency); Uncontrollable hypertension and portal hypertension; Hepatic artery-portal vein or hepatic vein fistula or portal vein trunk cancer thrombus; A large amount of ascites or refractory ascites; With distant metastasis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guoliang Shao
Phone
+8613958183472
Email
Shaoguoliang666@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoliang Shao
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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