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Tislelizumab in Combination With TACE in Advanced Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Tislelizumab in combination with cTACE

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring TACE, tislelizumab

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18-70 years old on the day the patients voluntary to participate in the study and signing in ICF.
Histological or clinical diagnosis of HCC.
BCLC stage C patients ineligible for surgical resection or liver transplantation.
No prior systemic therapy for HCC (including immunotherapy).
Have at least one uni-dimensional lesion measurable by CT scan or magnetic resonance imaging per mRECIST.
Child-Pugh A-B7.
ECOG PS 0-1.
Adequate hematological function (absolute neutrophil count ≥ 1.5 X 109/L, platelets count≥50 X109/L, and hemoglobin ≥85 g/L); Adequate hepatic function (both AST and ALT ≤ 3 ULN, serum total bilirubin ≤ 34.2 umol/L or 2mg/dl, serum albumin ≥ 29g/L); Adequate renal function (eGFR > 30 ml/min/1.73 m2)
For patients with HBV or HCV infection, HBV DNA less than 500 IU/ml (2500 copies/ml) or HCV RNA detectable.
life expectancy of more than 3 months.
Patients must be able to understand and willing to sign a written informed consent document.
Patients suitable for TACE therapy assessed by investigators.

Exclusion Criteria:

Tumor thrombus involving main trunk of portal vein or inferior vena cava.
Prior local-regional therapy before beginning of study treatment (surgery or ablation allowed at BCLC stage 0-B) or radiotherapy on liver cancer.
Disease history of grade 2 or more hepatic encephalopathy.
Extrahepatic metastasis on baseline imaging.
HIV infection or syphilis.
Prior therapies with any anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 agents.
Tumor diffuse.

Sites / Locations

Centre of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Southeast UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tislelizumab in combination with cTACE

Arm Description

Tislelizumab in combination with on-demanded cTACE

Outcomes

Primary Outcome Measures

TTP assessed by independent review committee(IRC)

Defined as the time from the date of first cTACE to the date of first documentation of disease progression per mRECIST. When pseudoprogression is suspected by investigator, tumor response will be re-assessed per iRECIST to confirm (also applicable for secondary endpoint of efficacy).

Secondary Outcome Measures

TTP assessed by investigators

Defined as the time from the treatment initiation to the date of the first objectively documented tumor progression, assessed by investigators per mRECIST.

PFS

Defined as the time from the treatment initiation to the date of the first objectively documented tumor progression or death, whichever occurs first, assessed by IRC and investigators, respectively, per mRECIST.

ORR

Defined as the proportion of patients with a documented CR or PR, assessed by IRC and investigators, respectively, per mRECIST.

DCR

Defined as the proportion of patients whose best overall response (BOR) is CR, PR, or SD, assessed by IRC and investigators, respectively, per mRECIST.

DOR

Defined as the time from the first confirmation of objective remission (CR or PR) to the first recording of disease progression or death, whichever occurs first, assessed by IRC and investigators, respectively, per mRECIST.

Defined as the time from the treatment initiation to the date of death due to any cause.

Safety

NCI-CTCAE v5.0.

Full Information

NCT ID

NCT04652492

First Posted

November 26, 2020

Last Updated

November 26, 2020

Sponsor

Zhongda Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04652492

Brief Title

Tislelizumab in Combination With TACE in Advanced Hepatocellular Carcinoma

Official Title

A Multicentric, Open-Label Study to Evaluate Tislelizumab in Combination With Transarterial Chemoembolization as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Recruiting

Study Start Date

October 27, 2020 (Actual)

Primary Completion Date

November 2022 (Anticipated)

Study Completion Date

November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhongda Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

A multicentric, open-label, single-arm prospective study to assess the efficacy and safety of tislelizumab combined with TACE as first-line treatment in patients with unresectable BCLC stage C HCC.

Detailed Description

This is a multicentric, open-label, single-arm prospective study to assess the efficacy and safety of tislelizumab combined with conventional transarterial chemoembolization(cTACE) as first-line treatment in BCLC stage C HCC patients without extrahepatic spread. The primary endpoint is time to progression (TTP).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

TACE, tislelizumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tislelizumab in combination with cTACE

Arm Type

Experimental

Arm Description

Tislelizumab in combination with on-demanded cTACE

Intervention Type

Drug

Intervention Name(s)

Tislelizumab in combination with cTACE

Other Intervention Name(s)

BGB-A317

Intervention Description

On-demanded cTACE in combined with tislelizumab (200mg q3w ivgtt on day 4 of each 21-day cycle)

Primary Outcome Measure Information:

Title

TTP assessed by independent review committee(IRC)

Description

Time Frame

up to 24 months after enrollment or study close

Secondary Outcome Measure Information:

Title

TTP assessed by investigators

Description

Defined as the time from the treatment initiation to the date of the first objectively documented tumor progression, assessed by investigators per mRECIST.

Time Frame