Hepatocellular Carcinoma, Transarterial Chemoembolization
Conditions
Brief summary
Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world. Hepatic resection or liver transplantation is the radical method to cure the disease. However, due to multiple tumors or poor hepatic function reserve in cirrhosis, surgical treatment is suitable for early-stage and well reserved liver function patients. Therefore, in clinical practice, transarterial chemoembolization (TACE) is a preferential and standard treatment of unresectable HCC. TACE has been proved to provide outstanding efficacy for treating advanced stage HCC patients. However, TACE is associated with a high rate of treatment failure for advanced HCC patients. EACH trial opened the door to FOLFOX-based system chemotherapy for advanced HCC patients. Recently, investigators have showed that hepatic arterial infusion of FOLFOX-based chemotherapy (HAIC) was safe and efficient for advanced HCC patients. The combination of TACE with HAIC (TACE-HAIC) was proved to increase the local doses of chemotherapeutic agents in the liver, reduce the viability of HCC cells and increase the hepatectomy rate in our previous study. Levatinib is a new treatment and offers relative high overall response rate for advanced HCC, which was approved in China and Japan. However, whether the combination of TACE-HAIC and Lenvatinib would increse tumor control for unresectable patients is still unknown. Thus, this single arm, phase 2 study is designed to analyze the safety and efficacy TACE-HAIC plus Lenvatinib for patients with unresectalbe HCC.
Interventions
PROCEDURETACE-HAIC plus lenvatinib
chemo-lipiodolization with EADM (30mg/m2), followed by FOLFOX-based chemotherapy artery infusion (Oxa 85mg/m2, 5-Fu 400 mg/m2, 5-Fu 1200mg/m2). Lenvatinib was administrated two or four days after TACE-HAIC, with 8mg for patients weight \<60kg, or 12mg for patients weight more than 60Kg.
Sponsors
Yunfei Yuan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 years 1. The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL) 2. unresectable disease, stage BCLC B/C 3. No previous anti-HCC treatment 4. Eastern Co-operative Group performance status 2 or less 5. Liver function: Child's A or B (score \< 7)
Exclusion criteria
* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy 1. underlying serve cardiac or renal diseases 2. Known or suspected allergy to the investigational agent or any agent given in association with this trial 3. Patients ineligible for hepatic artery embolization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival | 6-12 months | the time from assignment to progression, death or last follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 6-12 months | the time from assignment to death or last follow-up |
| overall response rate | 6-12 months | Objective response rate defined as confirmed complete response or partial response under mRECIST 1.1 criteria |
| adverse effects | 6-12 months | Frequency and severity of adverse effects as defined by CTCAE version 5 |
Countries
China
Contacts
Primary ContactJiliang Qiu
Outcome results
None listed