Anti-PD-1 Antibody Plus DEB-TACE for BCLC Stage A/B HCC

Phase 2

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Sintilimab; Drug: DEB-TACE

• Registration Number: NCT04174781
• Lead Sponsor: Zhejiang University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2019-11-20
• Study First Submitted: 2019-11-20
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-22
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-09
• Primary Completion: 2022-07-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DEB-TACE+Sintilimab	DEB-TACE	Participants with BCLC Stage A/B Hepatocellular Carcinoma Beyond the Milan Criteria
DEB-TACE+Sintilimab	Sintilimab	Participants with BCLC Stage A/B Hepatocellular Carcinoma Beyond the Milan Criteria

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) per mRECIST	36 months	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).

Secondary Outcome Measures

Name	Time	Method
12 mo PFS rate	36 months	The percentage of patients who have not progressed or relapsed or death at the 12 mo time point since the first time of treatment.
Pathological Response	6 months	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.
Disease Control Rate (DCR) per mRECIST	36 months	The proportion of complete response, partial response or stable disease as optimal response among all treated patients according to mRECIST.
Overall survival (OS)	36 months	The duration from treatment initiation to death from any cause.
Objective Response Rate (ORR) per mRECIST	36 months	The proportion of complete response or partial response as optimal response among all treated patients according to mRECIST.
Adverse events (AEs)	36 months	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.

Trial Locations

Locations (1)

the First Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China