Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

A Phase 2 Study to Investigate the Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib in Patients With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04401800
• Other study ID #: BGB-A317-211
• Secondary ID: CTR20200972
• Status: Completed
• Phase: Phase 2
• Start date: September 4, 2020
• Est. completion date: February 18, 2024

Study information

• Verified date: May 2024
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to assess the preliminary antitumor activity as indicated by overall response rate (ORR) of tislelizumab in combination with lenvatinib in participants with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 18, 2024
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Key Inclusion Criteria:

1. Unresectable locally advanced or metastatic HCC, which must be confirmed by histologically or cytologically. Fibrolamellar, sarcomatoid, or mixed cholangiocarcinoma histology confirmed by histologically or cytologically is excluded.

2. Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease that is not amenable to or has progressed after loco-regional therapy and is not amenable to a curative treatment approach

3. Did not receive any systemic treatment before and is unwilling to accept standard of care treatment or not suitable for standard of care treatment as judged by investigators

4. European Cancer Oncology Group (ECOG) Performance Status = 1

5. Child-Pugh A classification for liver function assessed within 7 days of first dose of study drugs

Key Exclusion Criteria:

1. Active autoimmune diseases or history of autoimmune diseases that may relapse

2. Any active malignancy = 2 years before the first dose of study drugs except for specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)

3. Uncontrolled diabetes or > Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management, or = Grade 3 hypoalbuminemia = 14 days before the first dose of study drugs

4. Any known brain or leptomeningeal metastases

5. Concurrent participation in another therapeutic clinical study

NOT: Other protocol defined Inclusion/Exclusion criteria may apply NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Metastatic Hepatocellular Carcinoma
• Unresectable Hepatocellular Carcinoma

Intervention

Drug:
• Lenvatinib
Capsules administered orally once daily
• Tislelizumab
200 mg intravenous (IV) infusion administered on Day 1 of each cycle

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing
China	West China Hospital ,Sichuan University	Chengdu	Sichuan
China	Nanfang Hospital	Guangzhou	Guangdong
China	Sun Yat-sen University - Cancer Center (SYSUCC)	Guangzhou
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	The First Affiliated Hospital of Xi 'an Jiaotong University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR) as assessed by Central Imaging Facility based on RECIST v1.1		Up to 12 months
Secondary	Number of participants experiencing Adverse Events (AEs)		Up to 12 months
Secondary	Number of participants experiencing Severe Adverse Events (SAEs)		Up to 12 months
Secondary	Overall Response Rate (ORR)		Up to 12 months
Secondary	Duration Of Response (DOR)		Up to 12 months
Secondary	Disease Control Rate (DCR)		Up to 12 months
Secondary	Progression-Free Survival (PFS)		Up to 12 months