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

Fudan University

Status and phase: Not yet enrolling; Phase 2

Conditions: Hepatocellular Cancer

Treatments: Drug: SHR-1826; Drug: SHR-1826 and immunotherapy combination therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06935175

HCC-2nd-IIT-SHR1826-SHR1316

Details and patient eligibility

About

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.

Enrollment: 53 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

SHR-1826 monotherapy arm

Experimental group

Treatment:

Drug: SHR-1826

SHR-1826 and immunotherapy combination therapy

Experimental group

Treatment:

Drug: SHR-1826 and immunotherapy combination therapy