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NCT Number: NCT06935175

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1.18-75 years old, male or female.

2.Hepatocellular carcinoma diagnosed histologically or cytologically, and not suitable for radical surgery;

3.Failure of at least one line of standard treatment (progression or intolerance);

4.According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there is at least one measurable lesion diagnosed by imaging (a lesion that has received local treatment needs to show clear progression to be considered a measurable lesion);

5.Expected survival time ≥ 12 weeks;

6.Normal function of major organs;

7.The subject voluntarily participates in this study, signs the informed consent form, has good compliance, and cooperates with the follow-up.

Exclusion criteria

  • 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);
  • Have a history of abdominal wall fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months before the start of treatment in the study;
  • Other situations in which the investigator deems that the subject should not be included.

Treatment and study plan

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.

Primary outcomes

  1. Objective Response Rate (ORR) by RECIST V1.1

    Time frame: up 2 years

    The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by RECIST V1.1.

Secondary outcomes

  1. Objective Response Rate (ORR) by mRECIST

    Time frame: up 2 years

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

  2. Disease control rate (DCR) by RECIST V1.1

    Time frame: up 2 years

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

  3. Progression-free survival (PFS)

    Time frame: up 2 years

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

  4. Overall survival (OS)

    Time frame: up 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guoming Shi, M.D

CONTACT

[email protected]

13916969578

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 20, 2025
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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