Status:
COMPLETED
Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma
Lead Sponsor:
BeiGene
Conditions:
Hepatocellular Carcinoma
Unresectable Hepatocellular Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The primary objective of this study was to assess the preliminary antitumor activity as indicated by overall response rate (ORR) of tislelizumab in combination with lenvatinib in participants with unr...
Eligibility Criteria
Inclusion
- Key
- Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
- 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.
- 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
- 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
- At least 1 measurable lesion as defined by RECIST v1.1
- European Cancer Oncology Group (ECOG) Performance Status ≤ 1
- Child-Pugh A classification for liver function assessed within 7 days of first dose of study drugs
- Key
Exclusion
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- 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)
- 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
- Any known brain or leptomeningeal metastases
- 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.
Key Trial Info
Start Date :
September 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2024
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04401800
Start Date
September 4 2020
End Date
February 18 2024
Last Update
March 10 2025
Active Locations (9)
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1
Anhui Provincial Hospital
Hefei, Anhui, China, 230000
2
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
3
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
4
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515