NCT04401800CompletedPhase 2
Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma
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
Source: ClinicalTrials.gov · Last updated 10 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 64 (actual)
- First submitted
- 21 May 2020
- Start date
- 4 Sept 2020
- Primary completion date
- 1 Dec 2022
- Lead sponsor
- BeiGene
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04401800
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 64
- From 4 Sept 2020 to the primary completion date, 1 Dec 2022
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Active autoimmune diseases or history of autoimmune diseases that may relapse
Lab values
- 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
Age
- 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)
Other
- Any known brain or leptomeningeal metastases
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| West China Hospital，Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Nanfang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Zhejiang University College of Medicine Second Affiliated Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The First Affiliated Hospital of Xian Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.