Liver Tumor
Conditions
Keywords
Large hepatocellular carcinoma, Lenvatinib, TACE, Microwave ablation
Brief summary
To explore the objective effectiveness and safety of TACE combined with Lenvatinib in the treatment of advanced liver cancer. After successful down-stage, radical microwave ablation was further performed.
Detailed description
The purpose of this study is to explore the objective effective rate of TACE combined with Lenvatinib in the treatment of locally advanced liver cancer, so as to provide a new idea for the radical microwave ablation treatment mode after the decline of locally advanced liver cancer.
Interventions
Three days after the first TACE treatment, when the liver function was evaluated as grade A / B, Lenvatinib was taken orally, 8mg / day (body weight less than 60kg) or 12mg / day (body weight equal to or more than 60kg). Lenvatinib reduction standard: 8mg / day; 4mg / day; 4mg, the next day.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18-75 years with hepatocellular carcinoma have an expected survival of at least 3 months; * Number of tumors ≤ 3; * Large hepatocellular carcinoma with tumor diameter ≥ 7 cm; * Patients without inferior vena cava tumor thrombus, portal vein tumor thrombus and cholangiocarcinoma thrombus; * Although there is arteriovenous fistula or arterioportal fistula, it can be completely blocked; * Child Pugh grade A or B of liver function; ECoG physical fitness score \< 2; * No bleeding tendency, normal coagulation function or coagulation dysfunction can be corrected after treatment; * Leukocyte count ≥ 3.0 × 109/L； * Hemoglobin ≥ 8.5g/dl; * Platelet count ≥ 50 × 109/L； * The international normalized ratio of prothrombin time (INR) ≤ 2.3 or prothrombin time (PT) does not exceed the upper limit of normal control for 3 seconds; * Serum creatinine was less than 1.5 times of the upper limit of normal; * Patients and / or family members agree to join the clinical trial and sign the informed consent form
Exclusion criteria
* Diffuse hepatocellular carcinoma; * Portal vein tumor thrombus; * Combined with tumor thrombus of hepatic vein and inferior vena cava; * Patients with lymph node metastasis and extrahepatic distant metastasis; * The liver function was classified as child Pugh C and could not be improved by liver protection treatment; * Arteriovenous fistula or arterioportal fistula with ineffective intervention; * Uncorrectable coagulation dysfunction and obvious hemogram abnormalities, with obvious bleeding tendency; * Intractable massive ascites; * ECoG physical fitness score \> 2 points; * Combined with active infection, especially bile duct inflammation; * Serious heart, lung, kidney, brain and other important organ diseases; * Note: see attached table 1 for child Pugh classification of liver function; See attached table 2 for ECoG physical fitness score
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Down stage rate | 4 months | if the patient achieve any of these three criteria： ① the patient was downgraded from BCLC stage C to BCLC stage B (portal branch tumor thrombus was inactive, the focus was less than or equal to 7cm; or the focus did not invade the surrounding tissue after shrinking) or Milan standard (single tumor diameter was not more than 5cm or less than or equal to 3 tumors, and the maximum diameter was not more than 3cm, without vascular invasion). ② Liver function reaches child Pugh grade A or B; ③ The patient is in good health and can tolerate ablation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RFS | 3 years | Recurrence free survival indicates the length of time after MWA for a cancer ends that the patient survives without any signs or symptoms of HCC |
| Objective response rate | 3 years | Change of the tumor size according to the modified response evaluation criteria in solid tumors (mRECIST) \[see attached table 3\], the efficacy is defined as CR (complete remission), PR (partial remission), SD (stable) and PD (Progress) |
| Changes of liver and kidney function | 3 years | Changes of liver and kidney function index from blood biochemistry compared to baseline |
| TACE frequency and ablation frequency | 3 years | To access the times and frequency of TACE and ablation |
Countries
China
Contacts
Primary ContactJinhua Huang, Ph.D
Outcome results
None listed