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NCT04615143RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 9 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
80 (estimated)
First submitted
28 Oct 2020
Start date
1 Dec 2020
Primary completion date
1 Dec 2026
Lead sponsor
Sun Yat-sen University
NCT number
NCT04615143

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 80
  • From 1 Dec 2020 to the primary completion date, 1 Dec 2026
  • 1 site 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

  • Previously received any transarterial chemoembolization and immune therapy and other local or systemic liver cancer treatments, except for curative ablation;

Other illness

  • History of gastroesophageal varices or active cardia ulcers associated with a high risk of bleeding;
  • History of autoimmune disease or need to take immunosuppressant drugs for a long time;
  • History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);

Other

  • Extrahepatic metastasis;
  • Abnormal organ function

Who the study is looking for

  • Diagnosed as recurrent hepatocellular carcinoma after curative treatment;
  • The criteria for resectability is met;
  • Has at least one evaluable lesion according to the RECIST 1.1 standard and has not received local treatment;
  • Eastern Cooperative Oncology Group score 0-1, Child-pugh score 5-7;
  • Agree to biopsy and blood sample collection;
  • Adequate organ and marrow function.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
the First Affiliated Hospital of Sun Yat-sen University
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.