A prospective, randomized, placebo-controlled, double-blind, multicenter phase III registration clinical study to compare toripalimab (JS001) combined with lenvatinib versus placebo combined with lenvatinib as the 1st-line therapy for advanced hepatocellular carcinoma (HCC)

Conditions

Advanced hepatocellular carcinoma (HCC)

Brief summary

Overall survival (OS)

Detailed description

Efficacy: 1. ORR, DOR, DCR, TTP and PFS evaluated per RECIST v1.1 and mRECIST. 2. Six-month and one-year PFS rate and one-year and two-year OS rate in both groups., Safety: 1. Incidence, severity and prognosis of adverse event (AE) and serious adverse event (SAE) judged in accordance with NCI-CTCAE v5.0; vital signs, ECG and abnormal laboratory examinations., PK and immunogenic parameters: 1. PK profile of toripalimab. 2. Analysis of anti-drug antibody (ADA) during treatment. 3. Immunogenicity of toripalimab: including incidence and titer of antidrug antibody (ADA), and the presence of neutralising antibody (Nab) in ADA-positive samples (if necessary)., Other study endpoints: 1. ORR, DOR, DCR, TTP and PFS evaluated by investigators using iRECIST criteria; 2. Correlation between PD-L1 expression level in tumor tissue, proportion of strong positive expression of PD-L1, tumor mutation burden (TMB) and the efficacy of toripalimab combined with lenvatinib

Related papers

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Interventions

DRUGToripalimab

DRUGLENVIMA 4 mg hard capsules

DRUGToripalimab Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival (OS)	—

Secondary

Measure	Time frame
Efficacy: 1. ORR, DOR, DCR, TTP and PFS evaluated per RECIST v1.1 and mRECIST. 2. Six-month and one-year PFS rate and one-year and two-year OS rate in both groups., Safety: 1. Incidence, severity and prognosis of adverse event (AE) and serious adverse event (SAE) judged in accordance with NCI-CTCAE v5.0; vital signs, ECG and abnormal laboratory examinations., PK and immunogenic parameters: 1. PK profile of toripalimab. 2. Analysis of anti-drug antibody (ADA) during treatment. 3. Immunogenicity of toripalimab: including incidence and titer of antidrug antibody (ADA), and the presence of neutralising antibody (Nab) in ADA-positive samples (if necessary)., Other study endpoints: 1. ORR, DOR, DCR, TTP and PFS evaluated by investigators using iRECIST criteria; 2. Correlation between PD-L1 expression level in tumor tissue, proportion of strong positive expression of PD-L1, tumor mutation burden (TMB) and the efficacy of toripalimab combined with lenvatinib	—

Measure

Time frame

Efficacy: 1. ORR, DOR, DCR, TTP and PFS evaluated per RECIST v1.1 and mRECIST. 2. Six-month and one-year PFS rate and one-year and two-year OS rate in both groups., Safety: 1. Incidence, severity and prognosis of adverse event (AE) and serious adverse event (SAE) judged in accordance with NCI-CTCAE v5.0; vital signs, ECG and abnormal laboratory examinations., PK and immunogenic parameters: 1. PK profile of toripalimab. 2. Analysis of anti-drug antibody (ADA) during treatment. 3. Immunogenicity of toripalimab: including incidence and titer of antidrug antibody (ADA), and the presence of neutralising antibody (Nab) in ADA-positive samples (if necessary)., Other study endpoints: 1. ORR, DOR, DCR, TTP and PFS evaluated by investigators using iRECIST criteria; 2. Correlation between PD-L1 expression level in tumor tissue, proportion of strong positive expression of PD-L1, tumor mutation burden (TMB) and the efficacy of toripalimab combined with lenvatinib

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Countries

Italy, Poland

Outcome results

None listed