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

NCT06935175 | Not Yet Recruiting Phase 2

• 1 other identifier: HCC-2nd-IIT-SHR1826-SHR1316
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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

Keywords

hepatocellular cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Objective Response Rate (ORR) by mRECIST

  up 2 years

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

  up 2 years

• Progression-free survival (PFS)

  up 2 years

• Overall survival (OS)

  up 2 years

Study Arms (2)

SHR-1826 monotherapy arm

EXPERIMENTAL

Drug: SHR-1826

SHR-1826 and immunotherapy combination therapy

EXPERIMENTAL

Drug: SHR-1826 and immunotherapy combination therapy

Interventions

SHR-1826 DRUG

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

SHR-1826 monotherapy arm

SHR-1826 and immunotherapy combination therapy DRUG

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

SHR-1826 and immunotherapy combination therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, male or female.
• Hepatocellular carcinoma diagnosed histologically or cytologically, and not suitable for radical surgery;
• Failure of at least one line of standard treatment (progression or intolerance);
• 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);
• Expected survival time ≥ 12 weeks;
• Normal function of major organs;
• The subject voluntarily participates in this study, signs the informed consent form, has good compliance, and cooperates with the follow-up.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, 200020, China

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Central Study Contacts

Guoming Shi, M.D

CONTACT

13916969578; shi.guoming@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 20, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)