About this trial
The study was designed to evaluate the efficacy and safety of SHR-1826 monotherapy or in combination with immunotherapy in the treatment of advanced hepatocellular cancer patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Known or suspected to have a severe allergic history to the drugs related to this study (including drugs of the same type);
Evidence of liver decompensation: including but not limited to symptomatic ascites, esophageal-gastric variceal bleeding, hepatic encephalopathy, hepatorenaHave central nervous system metastasis;l syndrome, sepsis, etc.;
Have central nervous system metastasis;
Have a history of organ transplantation or are preparing for organ transplantation (including but not limited to liver transplantation);
Trial design
Parallel
Treatments tested in this trial
SHR-1826
DrugSHR-1826 will be administrated per dose level in which the patients are assigned.
SHR-1826 and immunotherapy combination therapy
DrugSHR-1826 and immunotherapy will be administrated per dose level in which the patients are assigned.
Treatment groups
Trial outcomes
Primary outcomes
Objective Response Rate (ORR) by RECIST V1.1
The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by RECIST V1.1.
Secondary outcomes
Objective Response Rate (ORR) by mRECIST
The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by mRECIST.
Disease control rate (DCR) by RECIST V1.1
The DCR is defined as complete remission (CR) rate + partial remission (PR) rate + stable disease (SD).
Progression-free survival (PFS)
The PFS is defined as Time from the date of enrollment to of disease.
Overall survival (OS)
The OS is defined as time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.
Sponsors and contacts
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