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

Phase 2

Not yet recruiting

• Conditions: Hepatocellular Cancer
• Interventions: Drug: SHR-1826; Drug: SHR-1826 and immunotherapy combination therapy

• Registration Number: NCT06935175
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-11
• Study First Submitted QC: 2025-04-17
• Last Update Submitted: 2025-04-17
• Study First Posted: 2025-04-20
• Last Update Posted: 2025-04-20
• Study Start: 2025-05-01
• Primary Completion: 2027-05-31
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 53

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

1. Known or suspected to have a severe allergic history to the drugs related to this study (including drugs of the same type);
2. 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.;
3. Have central nervous system metastasis;
4. Have a history of organ transplantation or are preparing for organ transplantation (including but not limited to liver transplantation);
5. Have a history of abdominal wall fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months before the start of treatment in the study;
6. Other situations in which the investigator deems that the subject should not be included.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-1826 monotherapy arm	SHR-1826	-
SHR-1826 and immunotherapy combination therapy	SHR-1826 and immunotherapy combination therapy	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) by RECIST V1.1	up 2 years	The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by RECIST V1.1.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) by mRECIST	up 2 years	The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by mRECIST.
Disease control rate (DCR) by RECIST V1.1	up 2 years	The DCR is defined as complete remission (CR) rate + partial remission (PR) rate + stable disease (SD).
Progression-free survival (PFS)	up 2 years	The PFS is defined as Time from the date of enrollment to of disease.
Overall survival (OS)	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.

Trial Locations

Locations (1)

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, China