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

NCT ID: NCT06935175

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2028-05-31

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.

Conditions

Hepatocellular Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-1826 monotherapy arm

Group Type: EXPERIMENTAL

SHR-1826

Intervention Type: DRUG

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

SHR-1826 and immunotherapy combination therapy

Group Type: EXPERIMENTAL

SHR-1826 and immunotherapy combination therapy

Intervention Type: DRUG

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

Interventions

SHR-1826

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

Intervention Type: DRUG

SHR-1826 and immunotherapy combination therapy

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Zhongshan Hospital

Shanghai, , China

Countries

China

Central Contacts

Guoming Shi, M.D

Role: CONTACT

shi.guoming@zs-hospital.sh.cn

13916969578

Facility Contacts

Guoming Shi, M.D

Role: primary

shi.guoming@zs-hospital.sh.cn

13916969578

Other Identifiers

HCC-2nd-IIT-SHR1826-SHR1316

Identifier Type: -

Identifier Source: org_study_id