Nimotuzumab Combined With ICIs for the Treatment of Advanced Liver Cancer After First Line Treatment Failure

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL · May 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for advanced liver cancer, specifically a type called hepatocellular carcinoma (HCC). Researchers are looking at the effects of a medication called nimotuzumab when combined with immune checkpoint inhibitors, which help the body’s immune system fight cancer. This trial is for patients who have already tried one type of treatment but found it did not work or could not be tolerated.

To be eligible for this study, patients must have a confirmed diagnosis of advanced HCC and have experienced progression or intolerance after previous treatments. They should also have certain liver function scores and measurable cancer lesions. This trial is open to adults aged 62 to 28854, regardless of gender. Participants can expect to receive the study medication and will be closely monitored for their health and response to the treatment. It's important to know that this trial is currently recruiting participants, and anyone considering joining should discuss it with their doctor to see if it’s the right option for them.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects with histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC), or The clinical diagnosis meets the American Association of Liver Diseases (AASLD) diagnostic criteria for hepatocellular carcinoma；
• • Prior experience of targeted, immune, progression after conventional therapy, or intolerance (including TKIs,ICIs, chemotherapy, VEGF monoclonal antibody, or ICIs in combination with TKIs/VEGFs monoclonal antibody/chemotherapy)；
• • Child-Pugh liver function rating within 7 days prior to the first dose of study drug: Grade A or better grade B (≤ 7 points) ;
• • Phase B or C as assessed by BCLC; or Phase III as assessed by CNLC;
• • Within 4 weeks prior to the first dose, at least one measurable target lesion remained according to mRECIST v1.1；
• • EGFR postive and RAS wildtype；
• Exclusion Criteria:
• • Dignosised as hepatic cholangiocarcinoma, mixed cell carcinoma, or fibrolamellar cell carcinoma；
• • History of hepatic encephalopathy within 6 months prior to the first dose of this study；
• • Portal hypertension with endoscopic red signs, or those who are considered by the investigator to be at high risk of bleeding or who have had esophageal or gastric variceal bleeding within 6 months prior to the first dose；
• • Symptomatic brain or meningeal metastases (unless patient is treated\> 3 months, no evidence of progression on imaging within 4 weeks prior to treatment, and tumor-related clinical symptoms is stable)