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

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

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

Study Overview

• Status: Unknown
• Conditions: Carcinoma, Hepatocellular
• Intervention / Treatment: Device: TACE; Drug: Anlotinib Hydrochloride

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progress Free Survival	12 months

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Principal Investigator: Guoliang Shao, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 30, 2019
• Primary Completion (Anticipated): May 30, 2021
• Study Completion (Anticipated): October 30, 2021

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): August 26, 2019
• Last Update Submitted That Met QC Criteria: August 22, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: ALTNZJ-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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