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

A Study of SHR-1826 Monotherapy or in Combination With Immunotherapy in Patients With 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatocellular Cancer
• Intervention / Treatment: Drug: SHR-1826; Drug: SHR-1826 and immunotherapy combination therapy

• Study Type: Interventional
• Enrollment (Estimated): 53
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Guoming Shi, M.D; Phone Number: 13916969578; Email: shi.guoming@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai, China, 200020
    • Shanghai Zhongshan Hospital
    • Contact: Guoming Shi, M.D; Phone Number: 13916969578; Email: shi.guoming@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1826 monotherapy arm	Drug: SHR-1826; SHR-1826 will be administrated per dose level in which the patients are assigned.
Experimental: SHR-1826 and immunotherapy combination therapy	Drug: SHR-1826 and immunotherapy combination therapy; SHR-1826 and immunotherapy will be administrated per dose level in which the patients are assigned.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up 2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: hepatocellular cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms; Immunologic Factors; Physiological Effects of Drugs; Immunomodulating Agents
• Other Study ID Numbers: HCC-2nd-IIT-SHR1826-SHR1316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No