Rituximab Combined With Prior Therapy in Advanced Hepatocellular Carcinoma: Efficacy & Safety Study

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age17-79
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

Evaluation of the efficacy and safety of adding rituximab after failure of target immunotherapy in the Posterior treatment of advanced hepatocellular carcinoma

Eligibility criteria

Qualifiers

1)written informed consent signed prior to enrolment.

2) Age 17-79 years old (including boundary), male or female;

3) Subjects with histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC), or clinical diagnosis that meets the American Association of Liver Diseases (AASLD) diagnostic criteria for hepatocellular carcinoma

4) Previous progression or intolerance after failure to target, immunization, or conventional therapy (including TKI, ICI, chemotherapy, VEGF monoclonal antibody, or ICI combined with TKI/VEGF monoclonal antibody/chemotherapy)

Disqualifiers

1) Known hepatocholangiocarcinoma, mixed cell carcinoma, or fibrolamellar cell carcinoma

2) History of hepatic encephalopathy within 6 months prior to the first dose of this study

3) Portal hypertension with endoscopic red signs, or those who are considered by the investigator to have a high risk of bleeding or who have had esophageal or gastric variceal bleeding within 6 months before the first dose

4) Symptomatic brain or meningeal metastases (unless the patient has been >treated for 3 months, there is no evidence of progression in imaging results within 4 weeks before the first dose, and tumor-related clinical symptoms are stable)

Trial design

Treatments tested in this trial

  • Rituximab+PD-1 or PD-L1 inhibitors+targeted therapy

Treatment groups

20 Participants
are divided into 1 treatment group