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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunotherapy group | Treatment based on immunotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immune checkpoint inhibitor | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Absence of death of any cause | 3-years Followed up |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response | Tumor response to immune checkpoint inhibitor according to RECIST 1.1 | 3-years Followed up |
| Progress Free Survival | Absence of disease progression other than death |
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Inclusion Criteria:
Written informed consent must be obtained prior to any screening procedures.
Cytohistological confirmation is required for diagnosis of HCC.
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.
At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
Current cirrhotic status of Child-Pugh class A-B, with no encephalopathy. Ascites controlled by diuretics is permitted in this study.
Availability of a representative tumor tissue specimen (archival tumor tissue is allowed) at pre-screening.
astern Cooperative Oncology Group Scale for Assessment of Patient Performance Status ≤ 2.
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.
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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The patients aged from 18 to 75 years old were diagnosed as hepatocellular carcinoma by pathological diagnosis and were in stage C of BCLC.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Zhao, M.D. & Ph.D. | Contact | +86-20-87343272 | zhaoming@sysucc.org.cn | |
| Ning Lyu, M.D. | Contact | +86-20-87343272 | lvning@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ming Zhao, M.D. & Ph.D. | Department of Minimally Invasive and Interventional Radiology, Liver Cancer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Minimally Invasive and Interventional Radiology, Liver Cancer Study and Service Group, Sun Yat-sen University Cancer Center, | Guangzhou | Guangdong | 500060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34905388 | Result | Lyu N, Wang X, Li JB, Lai JF, Chen QF, Li SL, Deng HJ, He M, Mu LW, Zhao M. Arterial Chemotherapy of Oxaliplatin Plus Fluorouracil Versus Sorafenib in Advanced Hepatocellular Carcinoma: A Biomolecular Exploratory, Randomized, Phase III Trial (FOHAIC-1). J Clin Oncol. 2022 Feb 10;40(5):468-480. doi: 10.1200/JCO.21.01963. Epub 2021 Dec 14. | |
| 29471013 |
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|
| 3-years Followed up |
| Lyu N, Kong Y, Mu L, Lin Y, Li J, Liu Y, Zhang Z, Zheng L, Deng H, Li S, Xie Q, Guo R, Shi M, Xu L, Cai X, Wu P, Zhao M. Hepatic arterial infusion of oxaliplatin plus fluorouracil/leucovorin vs. sorafenib for advanced hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):60-69. doi: 10.1016/j.jhep.2018.02.008. Epub 2018 Feb 20. |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
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