This study aimed to evaluate the efficacy and the safety of the anti-programmed-death-1 antibody (anti-PD-1) Sintilimab Injection in combination with transarterial chemoembolization with drug-eluting beads(TACE-DEB) in patients with BCLC Stage A/B Hepatocellular Carcinoma Beyond the Milan Criteria.
Patients with hepatocellular carcinoma (HCC) of BCLC stage A/B exceeding the Milan criteria have a low resection rate and high postoperative recurrence rate, therefore, optimizing therapy for these patients is an important unmet need. This study aimed to investigate the efficacy and safety of preoperative DEB-TACE plus sintilimab for the treatment of patients with BCLC stage A/B HCC exceeding the Milan criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Sintilimab: 200mg iv Q3W D1
DEB-TACE(epirubicin 60mg) D1; Additional DEB-TACE procedures were carried out every 4-6 weeks based on tumor response. A treatment cycle was defined as one DEB-TACE procedure plus two doses of sintilimab. The combination of DEB-TACE and sintilimab was continued for a maximum of 3 cycles until surgical resection, radiologic disease progression, unacceptable toxicity, or withdrawal from the study, whichever occurred first.
the First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Progression Free Survival (PFS) per mRECIST
The duration from treatment initiation to PD in patients who cannot undergo surgery, or to the date of postoperative relapse in patients who receive surgery, or death for any reason, whichever occurs first (according to mRECIST).
Time frame: 36 months
12 mo PFS rate
The percentage of patients who have not progressed or relapsed or death at the 12 mo time point since the first time of treatment.
Time frame: 36 months
Overall survival (OS)
The duration from treatment initiation to death from any cause.
Time frame: 36 months
Pathological Response
Including Major Pathological response rate(MPR)and pathological complete response (pCR). MPR is defined as the presence of 10% or fewer viable tumour cells in the primary tumours. pCR is defined as no viable tumour cells in the specimen.
Time frame: 6 months
Objective Response Rate (ORR) per mRECIST
The proportion of complete response or partial response as optimal response among all treated patients according to mRECIST.
Time frame: 36 months
Disease Control Rate (DCR) per mRECIST
The proportion of complete response, partial response or stable disease as optimal response among all treated patients according to mRECIST.
Time frame: 36 months
Adverse events (AEs)
The incidence, relationship with study drugs, and severity level of all adverse events (AEs) according to CTCAE 5.0, treatment-emergent adverse events (TEAEs), treatment related adverse events (TRAEs), and serious adverse events (SAEs) and the changes in vital signs, physical examination results, and laboratory test results before, during, and after the treatment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 36 months