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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2024
Source BeiGene
Contact n/a
Is FDA regulated No
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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