A Study of SHR-1826 Monotherapy or in Combination With Immunotherapy in the Treatment of Advanced Hepatocellular Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Zhongshan Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • SHR-1826

    Drug

    SHR-1826 will be administrated per dose level in which the patients are assigned.

  • SHR-1826 and immunotherapy combination therapy

    Drug

    SHR-1826 and immunotherapy will be administrated per dose level in which the patients are assigned.

Treatment groups

53 Participants
are divided into 2 treatment groups
Group A: SHR-1826 monotherapy armExperimental treatment 1 intervention
Group B: SHR-1826 and immunotherapy combination therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
up 2 years

Secondary outcomes

1

Objective Response Rate (ORR) by mRECIST

The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by mRECIST.

Time frame
up 2 years
2

Disease control rate (DCR) by RECIST V1.1

The DCR is defined as complete remission (CR) rate + partial remission (PR) rate + stable disease (SD).

Time frame
up 2 years
3

Progression-free survival (PFS)

The PFS is defined as Time from the date of enrollment to of disease.

Time frame
up 2 years
4

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.

Time frame
up 2 years

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: