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Trial Title:
Adjuvant Tislelizumab Plus Lenvatinib for Patients at High-risk of HCC Recurrence After Curative Resection or Ablation
NCT ID:
NCT05910970
Condition:
Hepatocellular Carcinoma
Recurrence
Immune Checkpoint Inhibitor
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Recurrence
Lenvatinib
Tislelizumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adjuvant tislelizumab plus lenvatinib
Description:
Patients at high-risk of hepatocellular carcinoma recurrence after curative resection or
ablation will receive adjuvant tislelizumab plus lenvatinib treatment for six months, HCC
recurrence, or unacceptable adverse events.
Arm group label:
Adjuvant tislelizumab plus lenvatinib
Intervention type:
Drug
Intervention name:
Adjuvant tislelizumab
Description:
Patients at high-risk of hepatocellular carcinoma recurrence after curative resection or
ablation will receive adjuvant tislelizumab treatment for six months, HCC recurrence, or
unacceptable adverse events.
Arm group label:
Adjuvant tislelizumab
Summary:
Though hepatic resection and ablation are the curative treatments for patients with
hepatocellular carcinoma (HCC), the 5-years recurrence-free survival is lower than 30%.
In recent years, several immune checkpoint inhibitors have been approved in advanced or
unresectable HCC. No study about the safety and efficacy of adjuvant immune checkpoint
inhibitors for patients with HCC after hepatectomy is reported.
Detailed description:
Hepatic resection and ablation are the best treatments for patients with early stage
hepatocellular carcinoma (HCC) or selected intermediate or advanced disease. However, the
postoperative 5-years recurrent rate is up to 70%, for whom recurrence is a major cause
of death. In recent years, several immune checkpoint inhibitors have been approved in
advanced HCC by official guidelines. At the same time, four randomizead controlled trials
about adjvuant immune checkpoint inhibitors for postoperative HCC are ongoing. A
prospective cohort study found adjuvant immune checkpoint inhibitors with or without
tyrosine kinase inhibitors may improve recurrence-free survival of patients at high-risk
of HCC recurrence after curative resection (DOI: 10.1200/JCO.2023.41.16_suppl.4119.
Journal of Clinical Oncology 41, no. 16_suppl. 4119). Therefore, the investigators plan
to compare the safety and efficacy of adjuvant Tislelizumab plus lenvatinib to
Tislelizumab monotherapy for patients with high-risk factor of HCC recurrence after
curative resection and ablation in a multicentric, prospective study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age from 18 to 75 years (inclusive);
- Diagnosis of HCC confirmed by postoperative histopathology;
- Underwent curative resection, as defined based on intra- and postoperative criteria;
- With high-risk factors of recurrence after curative treatment, based on preoperative
radiological imaging or pathology reports indicating a tumor at least 5 cm in
diameter, micro- or macrovascular invasion (Vp1/Vp2), satellite or multinodular
tumors, and/or Grade 3/4 pathology;
- No residual cancer detected by radiological imaging in the liver within 8 weeks
after curative resection;
- Child-Pugh 5-7 scores liver function;
- Eastern Cooperative Oncology Group performance status of 0 or 1.
Exclusion Criteria:
- Received neoadjuvant immune checkpoint inhibitors or tyrosine kinase inhibitors
before resection or ablation;
- A history of other malignancies;
- History of active autoimmune or immunodeficiency diseases;
- Concurrent cardiac, pulmonary, cerebral, or renal dysfunction;
- Loss to follow-up within six months.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jian-Hong Zhong
Address:
City:
Nanning
Zip:
530021
Country:
China
Contact:
Last name:
Jian-Hong Zhong, PhD
Email:
zhongjianhong66@163.com
Start date:
February 15, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Guangxi Medical University
Agency class:
Other
Source:
Guangxi Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05910970
