Status:
NOT_YET_RECRUITING
A Study of SHR-1826 Monotherapy or in Combination With Immunotherapy in the Treatment of Advanced Hepatocellular Cancer
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Hepatocellular Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 18-75 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT06935175
Start Date
May 1 2025
End Date
May 31 2028
Last Update
April 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai Zhongshan Hospital
Shanghai, China, 200020