Immune Checkpoint Inhibitor Monotherapy or Combined With Molecular Targeted Drugs / Locoregional Therapy in the Treatment of Hepatocellular Carcinoma
Study Details
Study Description
Brief Summary
Non-intervention observation to evaluate the safety and efficacy of immune checkpoint inhibitors alone or combined with molecular targeted drugs / local interventional therapy in patients with advanced liver cancer, and to provide the best choice for the treatment of patients with advanced liver cancer in different stages.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Immunotherapy group Treatment based on immunotherapy. |
Drug: Immune checkpoint inhibitor
After signing the written informed consent form, patients begin to receive single or combined therapy with immune checkpoint inhibitor. The use of immune checkpoint inhibitors takes 3 weeks as a cycle, and the treatment dose for each cycle is carried out in accordance with the latest international authoritative guidelines.
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Outcome Measures
Primary Outcome Measures
- Overall Survival [3-years Followed up]
Absence of death of any cause
Secondary Outcome Measures
- Tumor Response [3-years Followed up]
Tumor response to immune checkpoint inhibitor according to RECIST 1.1
- Progress Free Survival [3-years Followed up]
Absence of disease progression other than death
Eligibility Criteria
Criteria
Inclusion Criteria:
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Written informed consent must be obtained prior to any screening procedures.
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Cytohistological confirmation is required for diagnosis of HCC.
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Patients with advanced (unresectable and/or metastatic, stage C based on Barcelona-Clinic Liver Cancer [BCLC] staging classification) hepatocellular carcinoma which would not be suitable for treatment with loco-regional therapies or have progressed following locoregional therapy such as surgical resection, percutaneous hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy.
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At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
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Current cirrhotic status of Child-Pugh class A-B, with no encephalopathy. Ascites controlled by diuretics is permitted in this study.
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Availability of a representative tumor tissue specimen (archival tumor tissue is allowed) at pre-screening.
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astern Cooperative Oncology Group Scale for Assessment of Patient Performance Status ≤
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Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial.
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Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to procedure:
Hemoglobin > 100g/L Absolute neutrophil count >3.0 ×109/L Neutrophil count > 1.5 ×109/L Platelet count ≥ 50.0 ×109/L Total bilirubin < 51 μmol/L Alanine transaminase (ALT) and aminotransferase (AST) < 5 x upper limit of normal Albumin > 28 g/L Prothrombin time (PT)-international normalized ratio (INR) < 2.3, or PT < 6 seconds above control Serum creatinine < 110 μmol/L
- Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
Exclusion Criteria:
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Received any prior systemic chemotherapy or molecular-targeted therapy for HCC such as sorafenib, lenvatinib.
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Previous local therapy completed less than 4 weeks prior to the dosing and, if present any related acute toxicity > grade 1.
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Any contraindications for Immune checkpoint inhibitor procedure
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Renal failure / insufficiency requiring hemo-or peritoneal dialysis.
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Known severe atheromatosis.
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Known uncontrolled blood hypertension (> 160/100 mm/Hg).
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Patients with any other malignancies within the last 3 years before study start.
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History of HCC tumor rupture.
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Patients with severe encephalopathy. Patients with known active bleeding (e.g. from GI ulcers, esophageal varices) within 2 months prior to baseline/screening visit or with history or evidence of inherited bleeding diathesis or coagulopathy.
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History of cardiac disease.
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Any other condition that would, in the Investigator's judgment, contraindicate patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable or unwilling to swallow medication, social/ psychological issues, etc.
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Patients who have received any other investigational agents within a period of time that is less than the cycle length used for that treatment or equal to 4 weeks (whichever is shorter) prior to starting study drug and recovered from any side effects to grade 1 or less.
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Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Department of Minimally Invasive and Interventional Radiology, Liver Cancer Study and Service Group, Sun Yat-sen University Cancer Center, | Guangzhou | Guangdong | China | 500060 |
Sponsors and Collaborators
- Sun Yat-sen University
Investigators
- Principal Investigator: Ming Zhao, M.D. & Ph.D., Department of Minimally Invasive and Interventional Radiology, Liver Cancer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B2022-341-01