Hepatocellular Carcinoma
Conditions
Keywords
Lenvatinib, PD-1, TACE, Downstaging
Brief summary
The purpose of this study is to assess the difference of safety and efficacy about PD-1 Antibody and Lenvatinib Plus transcatheter arterial chemoembolization (TACE) on downstaging hepatocellular carcinoma with BCLC B/C.
Interventions
COMBINATION_PRODUCTPD-1 and Lenvatinib Plus TACE
PD-1 Antibody and Lenvatinib Plus Transarterial chemoembolization(TACE )： Patients were recommended to receive TACE once every 6 weeks. Patients were recommended to begin oral administration of Lenvatinib 3 days after the first TACE treatment, and meanwhile to start intravenous drip of PD-1 antibody 3 days after the first TACE treatment, once every 3 weeks.
Sponsors
Fudan 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
1. Age ≥18 years old and ≤75 years old; 2. Clinically diagnosed as hepatocellular carcinoma, stage B/C of BCLC; 3. No history of severe arrhythmia or heart failure; 4. No history of severe ventilation dysfunction or severe pulmonary infection; 5. No acute or chronic renal failure, the creatinine clearance rate was \>40 mL/min; 6. Liver function Child A; 7. Blood routine: absolute neutrophils count ≥1.5×10\^9/L, Hb≥8.5g/L, PLT≥75×10\^9/L; 8. Coagulation function: INR≤2.3; 9. ECOG score \<2; 10. No local or systemic treatment, such as TACE, RFA, targeted drugs, traditional Chinese medicine, etc., before enrollment; 11. Expected survival ≥12 weeks; 12. At least one lesion can be measured and evaluated by CT/MRI according to RECIST 1.1 criteria; 13. Understand and sign the informed consent.
Exclusion criteria
1. Pregnant or lactating women; 2. Patients with other malignant tumors; 3. patients with complicated mental illness; 4. patients who have participated in other clinical trials in the last three months; 5. known or suspected allergy to any drug related to the study; 6. Patients with positive immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) 7. Patients treated with other targeted drugs, PD-L1 antibody and other immunotherapy or FOLFOX systemic chemotherapy after inclusion; 8. Patients with ≥1 + proteinuria indicated by urine routine will receive 24-hour urine protein detection, and patients with ≥1g 24-hour urine protein will not be included in the group. 9. Active autoimmune diseases that require systemic treatment (use of disease-alleviating agents, such as corticosteroids or immunosuppressants) 10. Patients with uncontrolled hepatitis B/C infection 11. Other conditions that the researcher considers not suitable for inclusion in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resection rate | 6 months after downstaging treatment | Resction rate refers to the proportion of patients who can receive radical surgery after downstaging treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (safety) | 6 months | Postoperative adverse events (safety ) will be evaluated according to the NCI CTCAE Version 4.03.The number and severity of treatment-related side effects, including AE and SAE, will be recorded during treatment. |
| Overall survival (OS) | 2 years | The duration from the date of recruitment to the date of death from any cause. |
| Objective response rate (ORR) | 6 months | ORR is defined as the percentage of participants who have a confirmed complete response or partial response according to RECIST 1.1 or mRECIST. |
| Progression free survival (PFS) | 6 months | PFS is defined as the time from enrollment of the trial to the first documented disease progression or death due to any cause. |
Countries
China
Contacts
Primary ContactLunxiu Qin, M.D
Outcome results
None listed