Transcatheter Arterial Chemoembolization Combined With Lenvatinib and Sintilimab for Unresectable Advanced Hepatocellular Carcinoma: An Open-label, Single-arm, Single-center, Prospective Study
Overview
- Phase
- Phase 2
- Intervention
- TACE combined with lenvatinib and sintilimab
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Sponsor
- Second Affiliated Hospital of Guangzhou Medical University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Progression free survival (PFS) assessed by investigators according to Modified RECIST (mRECIST)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This study will evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and sintilimab in patients with unresectable advanced hepatocellullar carcinoma (HCC).
Detailed Description
This is a Phase II study to evaluate the efficacy and safety of TACE combined with lenvatinib and sintilimab in patients with advanced HCC. 30 subjects with advanced HCC (Barcelona-Clinic- Liver-Cancer \[BCLC\] stage C, or China liver cancer staging \[CNLC\] IIIa and IIIb) will be enrolled in the study. Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd and sintilimab (200mg I.V. q3w) will be started at 3-7 days after the first TACE. TACE will be repeated if clinically indicated based on the evaluation of follow-up laboratory and imaging examination. Lenvatinib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Patients will be allowed to have lenvatinib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Advanced HCC (BCLC stage C, or CNLC IIIa and IIIb ) with diagnosis confirmed by histology/cytology or clinically
- •Disease not amenable to curative therapies but amenable to TACE
- •At least one measurable untreated lesion
- •No prior systemic therapy for HCC
- •Child-Pugh score 5-7
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
- •Adequate organ and hematologic function
- •Life expectancy of at least 3 months
- •For women of childbearing potential and for men: agreement to remain abstinent
Exclusion Criteria
- •Diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- •Diffuse HCC
- •Portal vein tumor thrombus (PVTT) involves the main trunk and contralateral branch or upper mesenteric vein
- •Inferior vena cava tumor thrombus
- •Metastatic disease that involves major airways or blood vessels
- •Symptomatic, untreated or progressing central nervous system metastasis
- •Uncontrolled tumor-related pain
- •Patients who received prior systemic therapy, immunotherapy, TACE, transcatheter arterial radioembolization (TARE), transcatheter arterial embolization (TAE), hepatic arterial infusion chemotherapy (HAIC) or radiation therapy for HCC
- •Treatment with systemic immunostimulatory agents
- •Use of herbal therapies or traditional Chinese medicines with anti-cancer activity within 2 weeks
Arms & Interventions
TACE-Len-Sin
TACE combined with lenvatinib and sintilimab.
Intervention: TACE combined with lenvatinib and sintilimab
Outcomes
Primary Outcomes
Progression free survival (PFS) assessed by investigators according to Modified RECIST (mRECIST)
Time Frame: 24 months
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Secondary Outcomes
- Adverse Events (AEs)(24 months)
- Progression free survival (PFS) assessed by investigators according to Response Evalutaion Criteria in Solid Tumors (RECIST) v1.1 and immune-related RECIST (irRECIST).(24 months)
- Objective response rate (ORR) assessed by investigators according to RECIST 1.1 and irRECIST.(24 months)
- Disease control rate (DCR) assessed by investigators according to RECIST 1.1 and irRECIST.(24 months)
- Duration of response (DOR) assessed by investigators according to RECIST 1.1 and irRECIST.(24 months)
- Overall survival (OS)(24 months)
- ORR assessed by investigators according to mRECIST.(24 months)
- DCR assessed by investigators according to mRECIST.(24 months)
- DOR assessed by investigators according to mRECIST.(24 months)