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

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Apr 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SHR-1826, either on its own or combined with immunotherapy, for people with advanced hepatocellular cancer, which is a type of liver cancer. The main goal is to find out how effective and safe this treatment is for patients who cannot have surgery and have already tried at least one other standard treatment that didn’t work or caused side effects.

To participate in this trial, you need to be between 18 and 75 years old and have been diagnosed with hepatocellular cancer that can’t be treated with surgery. You should also have at least one measurable tumor that shows some growth after previous treatments and expect to live for at least 12 more weeks. If you join, you’ll be monitored closely to see how you respond to the treatment. It’s important to know that this trial is not yet recruiting participants, so it’s a good idea to talk to your doctor about any questions you might have or to see if this trial might be right for you in the future.

Gender

ALL

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.