Clinical trial NCT04401800: Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Unresectable Hepatocellular Carcinoma
Metastatic Hepatocellular Carcinoma
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2020-05-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) by central site imaging facility per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.


Eligibility criteria: Key Inclusion Criteria:

1. Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
2. 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.
3. 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
4. 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
5. At least 1 measurable lesion as defined by RECIST v1.1
6. European Cancer Oncology Group (ECOG) Performance Status ≤ 1
7. 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.

Primary outcomes:
measure: Overall Response Rate (ORR) as Assessed by Central Imaging Facility Based on RECIST v1.1
timeFrame: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation and Modification
timeFrame: From the date of the first dose of study drug up to 30 days after last dose of study drug (maximum time on treatment was 12 months)
measure: Objective Response Rate (ORR) as Assessed by the Investigator Based on RECIST v1.1
timeFrame: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; i.e., up to 27 months
measure: Objective Response Rate (ORR) as Assessed by the Investigator and Central Site Imaging Facility Based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
timeFrame: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months
measure: Objective Response Rate (ORR) as Assessed by the Investigator and Central Site Imaging Facility Based on Immune Related Response Evaluation Criteria in Solid Tumors (iRECIST)
timeFrame: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months
measure: Duration of Response (DOR) As Assessed by The Investigator Based on RECIST v1.1
timeFrame: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months)
measure: Duration of Response (DOR) As Assessed by The Central Site Imaging Facility Based on RECIST v1.1
timeFrame: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months)
measure: Duration of Response (DOR) As Assessed by The Investigator Based on mRECIST
timeFrame: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months)
measure: Duration of Response (DOR) As Assessed by the Central Site Imaging Facility Based on mRECIST
timeFrame: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months)
measure: Duration of Response (DOR) As Assessed by The Investigator Based on iRECIST
timeFrame: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months)
measure: Duration of Response (DOR) As Assessed by The Central Site Imaging Facility Based on iRECIST
timeFrame: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurs first (up to 35 months)
measure: Disease Control Rate (DCR) As Assessed by The Investigator and Central Site Imaging Facility Based on RECIST v1.1
timeFrame: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months
measure: Disease Control Rate (DCR) As Assessed by The Investigator and Central Site Imaging Facility Based on mRECIST
timeFrame: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months
measure: Disease Control Rate (DCR) As Assessed by The Investigator and Central Site Imaging Facility Based on iRECIST
timeFrame: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months
measure: Progression Free Survival (PFS) As Assessed by The Investigator Based on RECIST v1.1
timeFrame: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)
measure: Progression Free Survival (PFS) As Assessed by The Central Site Imaging Facility Based on RECIST v1.1
timeFrame: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)
measure: Progression Free Survival (PFS) As Assessed by The Investigator Based on mRECIST
timeFrame: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)
measure: Progression Free Survival (PFS) As Assessed by The Central Site Imaging Facility Based on mRECIST
timeFrame: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)
measure: Progression Free Survival (PFS) As Assessed by The Investigator Based on iRECIST
timeFrame: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)
measure: Progression Free Survival (PFS) As Assessed by The Central Site Imaging Facility Based on iRECIST
timeFrame: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat Sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Xian
country: China
facility: The First Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
city: Shanghai
country: China
facility: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang University College of Medicine Second Affiliated Hospital
state: Zhejiang
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References: