Clinical trial NCT05609695: Immune Checkpoint Inhibitor Monotherapy or Combined With Molecular Targeted Drugs / Locoregional Therapy in the Treatment of Hepatocellular Carcinoma
Official title: Immune Checkpoint Inhibitor Monotherapy or Combined With Molecular Targeted Drugs / Locoregional Therapy in the Treatment of Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Immune Checkpoint Inhibitor Monotherapy or Combined With Molecular Targeting Drugs / Locoregional Therapy for Hepatocellular Carcinoma
Keywords: Immune checkpoint inhibitor
locoregional therapy
combination therapy
hepatocellular carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients aged from 18 to 75 years old were diagnosed as hepatocellular carcinoma by pathological diagnosis and were in stage C of BCLC.

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.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent must be obtained prior to any screening procedures.
2. Cytohistological confirmation is required for diagnosis of HCC.
3. 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.
4. At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
5. Current cirrhotic status of Child-Pugh class A-B, with no encephalopathy. Ascites controlled by diuretics is permitted in this study.
6. Availability of a representative tumor tissue specimen (archival tumor tissue is allowed) at pre-screening.
7. astern Cooperative Oncology Group Scale for Assessment of Patient Performance Status ≤ 2.
8. 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.
9. 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
10. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.

Exclusion Criteria:

1. Received any prior systemic chemotherapy or molecular-targeted therapy for HCC such as sorafenib, lenvatinib.
2. Previous local therapy completed less than 4 weeks prior to the dosing and, if present any related acute toxicity \> grade 1.
3. Any contraindications for Immune checkpoint inhibitor procedure
4. Renal failure / insufficiency requiring hemo-or peritoneal dialysis.
5. Known severe atheromatosis.
6. Known uncontrolled blood hypertension (\> 160/100 mm/Hg).
7. Patients with any other malignancies within the last 3 years before study start.
8. History of HCC tumor rupture.
9. 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.
10. History of cardiac disease.
11. 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.
12. 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.
13. 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.

Primary outcomes:
measure: Overall Survival
timeFrame: 3-years Followed up
Secondary outcomes:
measure: Tumor Response
timeFrame: 3-years Followed up
measure: Progress Free Survival
timeFrame: 3-years Followed up
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Minimally Invasive and Interventional Radiology, Liver Cancer Study and Service Group, Sun Yat-sen University Cancer Center,
state: Guangdong
Study officials:
affiliation: Department of Minimally Invasive and Interventional Radiology, Liver Cancer
name: Ming Zhao, M.D. & Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.