NCT04615143 Tislelizumab or Tislelizumab Combined With Lenvatinib Neo-adjuvant Treatment for Resectable RHCC
| NCT ID | NCT04615143 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sun Yat-sen University |
| Condition | Recurrent Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2020-12-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2020-12-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT04615143 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Recurrent Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04615143 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04615143 currently recruiting?
Yes, NCT04615143 is actively recruiting participants. Visit ClinicalTrials.gov or contact Sun Yat-sen University to inquire about joining.
Where is the NCT04615143 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT04615143 clinical trial?
NCT04615143 is sponsored by Sun Yat-sen University. The trial plans to enroll 80 participants.
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