Clinical trial NCT06261138: Survival Analysis: TACE vs. Combination Therapy in HCC
Official title: Survival Analysis of TACE Monotherapy vs. Combination Therapy in BCLC B and C Stage Hepatocellular Carcinoma: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Transarterial chemoembolization
Combination therapy
Survival
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with treatment-naive intermediate or advanced HCC who received with TACE alone or the combination therapy (TACE plus antiangiogenic agents with or without ICIs) at our institution

Brief summary: This retrospective observational study aimed to assess potential improvements associated with systemic therapies in patients receiving transarterial chemoembolization (TACE) for initially unresectable HCC.

Detailed description: Standard treatments provide limited benefits for patients with intermediate or advanced hepatocellular carcinoma (HCC). Recently, recommendations on multimodal treatment regimens for patients with locally advanced HCC have attracted much attention. Therefore, this retrospective research was designed to evaluate the clinical outcomes of TACE alone or in combination with immune and targeted therapy in the primary treatment for patients with intermediate to advanced stage HCC.

Eligibility criteria: Inclusion Criteria:

1. Both sexes, aged 18-75 years old; (2) HCC was clinically or pathologically diagnosed according to the American Association for Liver Diseases (ASSLD) criteria; (3) One or more tumor lesions could be measured according to modified response evaluation criteria in solid tumors (mRECIST) on enhanced CT or MRI; (4) For patients with Barcelona Clinic Liver Cancer (BCLC) stage B or stage C hepatocellular carcinoma (HCC) in Barcelona, and who are not suitable for surgical resection, it is recommended to undergo transarterial chemoembolization (TACE) or combination therapy involving TACE as the initial treatment; (5)Child-Pugh grade A or B, no hydrothorax, ascites and hepatic encephalopathy requiring treatment; (6) Eastern Cooperative Oncology Group performance status (ECOG-PS) score 0-1; (7) Have enough liver and kidney function in patients with appropriate laboratory indicators: hemoglobin concentration (HGB) hemoglobin, acuity 9.0 g/dl, neutrophils acuity 1500 cells/mm3, PLT 50 \* 109 / L, or serum propagated 28 g/L, or TBIL\< 50umol/L, ALT, AST\< 5 times the upper limit of normal, Bun, Cr\< 1.5 times the upper limit of normal, INR\< 1.7 or PT prolongation \< 4s

Exclusion Criteria:

1. Other malignant tumors outside HCC, such as liver metastasis of colon cancer; (2) Child-Pugh grade C; (3) Contraindications to TACE, lenvatinib or tislelizumab; (4) Any active autoimmune diseases or autoimmune disease, thyroid function hyperfunction or decline, which is to be bronchodilator treatment of asthma; (5) There are serious complications, including serious heart, lung, kidney, blood coagulation dysfunction; Important cardiovascular diseases such as heart disease of the definition of New York heart association level 3 or higher, instability during the treatment of myocardial infarction, arrhythmia, unstable angina, etc; (6) Past history of patients with idiopathic pulmonary fibrosis , Machine pneumonia (e.g., occlusive bronchiolitis), drug pneumonia, idiopathic pneumonia or chest CT screening to find evidence for an active pneumonia; (7) Patients with previous allogeneic stem cell or solid organ transplantation, including patients after liver transplantation; (8) Clinical data absence or incomplete information.

Primary outcomes:
measure: Progression Free Survival (PFS) per mRECIST
timeFrame: 12-48 months
Secondary outcomes:
measure: 12 months PFS rate
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 24-48 months
measure: Objective Response Rate (ORR) per mRECIST
timeFrame: 12-48 months
measure: Disease Control Rate (DCR) per mRECIST
timeFrame: 12-48 months
measure: Adverse events (AEs)
timeFrame: 12-48 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First Affiliated Hospital, Medical College of Zhejiang University
state: Zhejiang
Study officials:
References: