Carcinoma, Hepatocellular
Conditions
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.
Interventions
DEVICETACE
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.
DRUGAnlotinib Hydrochloride
Anlotinib hydrochloride capsule, according to the recommended dose, po, qd, continuous oral 2 weeks stop for 1 week, 3 weeks for a cycle.
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
TACE vs.TACE+Anlotinib
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 12 months | Progress Free Survival |
Countries
China
Contacts
Primary ContactGuoliang Shao
Outcome results
None listed