Clinical trial · Interventional
Tislelizumab or Tislelizumab Combined With Lenvatinib Neo-adjuvant Treatment for Resectable RHCC
Tislelizumab or Tislelizumab Combined With Lenvatinib Neo-adjuvant Treatment for Resectable Recurrent Hepatocellular Carcinoma：Phase II Non-randomized Control Clinical Trial
NCT04615143CI-TRIAL-00084495TALENTrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This non-randomized phase II clinical trial aimed to explore the efficacy and safety of Tislelizumab or Tislelizumab combined with Lenvatinib as neoadjuvant treatment for resectable RHCC patients
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tislelizumab | Drug | Tislelizumab | ALIAS |
| Tislelizumab combined with Levatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tislelizumab
- description
- Tislelizumab is one kind of PD-1 inhibitors. Patients enrolled will receive Tislelizumab as neoadjuvant treatment before surgery (200mg q3w\*2 cycles) and as adjuvant treatment after surgery for 1 year
- interventionNames
- Drug: Tislelizumab
- type
- EXPERIMENTAL
- label
- Tislelizumab Combined Lenvatinib
- description
- Patients enrolled will receive Tislelizumab combined Lenvatinibas neoadjuvant treatment before surgery (Tislelizumab: 200mg q3w\*2 cycles+Lenvatinib 8/12mg qd\*4weeks) and as adjuvant treatment after surgery for 1 year
- interventionNames
- Drug: Tislelizumab combined with Levatinib
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosed as recurrent hepatocellular carcinoma after curative treatment; 2. The criteria for resectability is met; 3. Has at least one evaluable lesion according to the RECIST 1.1 standard and has not received local treatment; 4. Eastern Cooperative Oncology Group score 0-1, Child-pugh score 5-7; 5. Agree to biopsy and blood sample collection; 6. Adequate organ and marrow function. Exclusion Criteria: 1. Previously received any transarterial chemoembolization and immune therapy and other local or systemic liver cancer treatments, except for curative ablation; 2. Extrahepatic metastasis; 3. History of gastroesophageal varices or active cardia ulcers associated with a high risk of bleeding; 4. History of autoimmune disease or need to take immunosuppressant drugs for a long time; 5. History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS); 6. Abnormal organ function
References
Publications (0)
Data not yet available
No reference posted for this study.