Tislelizumab in Combination With TACE in Advanced Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04652492
• Other study ID #: BGB-A317-2004-IIT
• Status: Recruiting
• Phase: Phase 2
• Start date: October 27, 2020
• Est. completion date: November 2023

Study information

• Verified date: November 2020
• Source: Zhongda Hospital
• Contact: Hai-Dong Zhu, MD
• Phone: 86-13851420979
• Email: zhuhaidong9509[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: November 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Centre of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	up to 24 months after enrollment or study close
Secondary	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.	An expected average of 8 months
Secondary	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.	An expected average of 8 months
Secondary	ORR	Defined as the proportion of patients with a documented CR or PR, assessed by IRC and investigators, respectively, per mRECIST.	An expected average of 8 months
Secondary	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.	An expected average of 8 months
Secondary	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.	An expected average of 8 months
Secondary	OS	Defined as the time from the treatment initiation to the date of death due to any cause.	An expected average of 24 months
Secondary	Safety	NCI-CTCAE v5.0.	up to 24 months after enrollment or study close