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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Carcinoma, Hepatocellular

Intervention / Treatment
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* Device: TACE
* Drug: Anlotinib Hydrochloride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: TACE vs.TACE+Anlotinib
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TACE group<br>Device: Transcatheter arterial chemoembolization(TACE) | Device: TACE<br>* 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.<br>|
| Experimental: TACE+Anlotinib group<br>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<br>* 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.<br>Drug: Anlotinib Hydrochloride<br>* Anlotinib hydrochloride capsule, according to the recommended dose, po, qd, continuous oral 2 weeks stop for 1 week, 3 weeks for a cycle.<br>* Other names: Anlotinib;|

What is the study measuring?
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Primary Outcome Measures

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