Hepatocellular Carcinoma
Conditions
Brief summary
This study will evaluate efficacy and safety of Toripalimab Injection (JS001) with or without Lenvatinib as a Neoadjuvant Therapy in patients with Resectable Hepatocellular Carcinoma (HCC)
Interventions
Given IV
DRUGToripalimab (JS001 ) Lenvatinib
Given IV 4 mg capsules
Sponsors
Shanghai Junshi Bioscience Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Confirmed by histopathological or cytological examination; The criteria for resectability is met; Has at least one evaluable lesion according to the RECIST 1.1 standard and has not received local treatment;
Exclusion criteria
Patients who previously received anti-programmed death receptor-1 (PD-1) antibody, anti-programmed death ligand-1 (PD-L1) antibody, anti-programmed death ligand-2 (PD-L2) antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies, including those who have participated in a JS001 clinical study; Patients with a history of gastroesophageal varices or active cardia ulcers associated with a high risk of bleeding; Patients who have upper gastrointestinal hemorrhage within 1 year; Patients known to have fibrous layer HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC; Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological response rate | Up to 2 months | CPR，MPR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of R0 resection | up to 8 months | Used for assessment of the feasibility of the neoadjuvant therapy. |
| Time to operation | up to 8 months | Used for assessment of the feasibility of the neoadjuvant therapy. |
| Objective response rate | up to 2 months | ORR is defined as the percentage of participants who achieved CR or PR |
| Overall survival | up to 3 years | Used for assessment of the efficacy. |
| Incidence of adverse events | up to 3 years | Graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Safety will be recorded through the incidence of adverse events, serious adverse events and specific laboratory abnormalities (worst grade) in each treatment arm. |
| Progression free survival | up to 3 years | Used for assessment of the efficacy. |
Countries
China
Outcome results
None listed