A Multicenter Registry Study on Stage III Hepatocellular Carcinoma in Unresectable CNLC Liver Cancer

Launched by FUDAN UNIVERSITY · Dec 20, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for patients with unresectable hepatocellular carcinoma, which is a type of liver cancer that cannot be surgically removed. The researchers want to see if combining Huaier Granules with standard targeted drugs and an antibody treatment (anti-PD-(L)1) is more effective and safe compared to using only the targeted drugs and the antibody treatment. The trial will also look at how this treatment affects the quality of life for patients.

To be eligible for the trial, participants must be at least 18 years old and diagnosed with this specific type of liver cancer. They should not have received any previous systemic therapy for liver cancer and have a certain level of liver function. Patients with stable hepatitis B or C infections may also participate. If you join the study, you will receive either the new treatment with Huaier Granules or the standard treatment. The trial is not yet recruiting participants, but once it starts, individuals will have the opportunity to contribute to important research that could lead to better treatments for liver cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ·≥ 18 years old;
• • Diagnosed as unresectable hepatocellular carcinoma through histopathological and/or cytological examination, or meeting the clinical diagnostic criteria for hepatocellular carcinoma in the 2022 edition of the guidelines for the diagnosis and treatment of primary liver cancer;
• • CNLC liver cancer stage III;
• • Liver function Child Pugh A or B grade 7 points;
• • Has not received systematic treatment in the past;
• • Patients with active HBV infection who meet one of the following conditions can be enrolled: ① Within 28 days before enrollment, the patient's HBV DNA is less than 500 IU/mL. If they have received anti HBV treatment, they need to continue their original antiviral treatment; If anti HBV treatment has not been received, it is necessary to receive anti HBV treatment throughout the entire course of medication (according to local treatment standards; for example, entecavir); ② For patients with HBV DNA\>500 IU/mL and who have not received antiviral therapy, they must receive at least 7 days of antiviral therapy (according to local treatment standards; for example, entecavir) before enrollment in this study, and are willing to continue receiving antiviral therapy during the study. Before enrollment, the serum HBV-DNA virus should be retested to decrease by more than 1 log value For patients with HBV DNA\>500 IU/mL and who have received antiviral therapy, they must receive at least 7 days of antiviral therapy (according to local treatment standards; for example, entecavir) before enrollment in this study, and are willing to continue receiving antiviral therapy during the study. Serum HBV-DNA virus levels should be retested before enrollment;
• • Active HCV infected individuals with stable disease status after treatment;
• • At least one tumor lesion available for evaluation;
• • Clear consciousness, language expression ability or reading ability, able to communicate normally, and cooperate to complete the questionnaire evaluation;
• • Voluntarily join this study and sign an informed consent form.
• Exclusion Criteria:
• • Simultaneously having two or more active primary malignant tumors;
• • Portal vein cancer thrombus invades the superior mesenteric vein;
• • Received radiation therapy within the past 4 weeks;
• • Expected survival time is less than 3 months;
• • Pregnant or lactating women or those planning to conceive;
• • Coagulation dysfunction (INR\>2.0, PT\>16 s) or diseases with a strong likelihood of bleeding (including but not limited to esophageal and/or gastric variceal bleeding, active ulcers, uncontrolled hypertension);
• • Refusing to cooperate with follow-up visits;
• • Other reasons led the researchers to believe that it was not suitable to participate in this study.