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Tislelizumab in Combination With TACE in Advanced Hepatocellular Carcinoma

NCT ID: NCT04652492

Last Updated: 2020-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-27

Study Completion Date

2023-11-30

Brief Summary

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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

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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).

Conditions

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Hepatocellular Carcinoma

Keywords

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TACE tislelizumab

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tislelizumab in combination with cTACE

Tislelizumab in combination with on-demanded cTACE

Group Type EXPERIMENTAL

Tislelizumab in combination with cTACE

Intervention Type DRUG

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

Interventions

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Tislelizumab in combination with cTACE

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

Intervention Type DRUG

Other Intervention Names

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BGB-A317

Eligibility Criteria

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Inclusion Criteria

1. 18-70 years old on the day the patients voluntary to participate in the study and signing in ICF.
2. Histological or clinical diagnosis of HCC.
3. BCLC stage C patients ineligible for surgical resection or liver transplantation.
4. No prior systemic therapy for HCC (including immunotherapy).
5. Have at least one uni-dimensional lesion measurable by CT scan or magnetic resonance imaging per mRECIST.
6. Child-Pugh A-B7.
7. ECOG PS 0-1.
8. 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)
9. For patients with HBV or HCV infection, HBV DNA less than 500 IU/ml (2500 copies/ml) or HCV RNA detectable.
10. life expectancy of more than 3 months.
11. Patients must be able to understand and willing to sign a written informed consent document.
12. Patients suitable for TACE therapy assessed by investigators.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhongda Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gao-jun Teng

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gao-Jun Teng, MD

Role: PRINCIPAL_INVESTIGATOR

Zhongda Hospital

Locations

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

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hai-Dong Zhu, MD

Role: CONTACT

Phone: 86-13851420979

Email: [email protected]

Rui-Jie Du, MD

Role: CONTACT

Phone: 86-25-83262224

Email: [email protected]

Other Identifiers

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BGB-A317-2004-IIT

Identifier Type: -

Identifier Source: org_study_id