Shanghai Zhongshan Hospital
Shanghai, 200020, China
NCT Number: NCT06935175
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 2
Shanghai, 200020, China
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
SHR-1826 will be administrated per dose level in which the patients are assigned.
SHR-1826 and immunotherapy will be administrated per dose level in which the patients are assigned.
Time frame: up 2 years
The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by RECIST V1.1.
Time frame: up 2 years
The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by mRECIST.
Time frame: up 2 years
The DCR is defined as complete remission (CR) rate + partial remission (PR) rate + stable disease (SD).
Time frame: up 2 years
The PFS is defined as Time from the date of enrollment to of disease.
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.
Contact information is provided by the study sponsor or research team.
Shanghai Zhongshan Hospital
Other
A Study of SHR-1826 Monotherapy or in Combination With Immunotherapy in Patients With Advanced Hepatocellular Cancer
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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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