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Tislelizumab or Tislelizumab Combined With Lenvatinib Neo-adjuvant Treatment for Resectable RHCC

ConditionRecurrent Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Extrahepatic metastasis;

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tislelizumab

    Drug

    Patients receive Tislelizumab on week 1 and week 4 (200mg, iv, q3w). After 2 cycles of Tislelizumab and evaluation of resectability, patients will receive surgery in 6 weeks after enrollment. Patients will receive Tislelizumab for 1 year (200mg, iv, q3w, 17 cycles) in 4-6 weeks after surgery.

  • Tislelizumab combined with Levatinib

    Drug

    Patients receive Tislelizumab on week 1 and week 4 (200mg, iv, q3w); Lenvatinib from Day1 to Day 28 (8/12mg qd). After neoadjuvant treatment and evaluation of resectability, patients will receive surgery in 6weeks after enrollment. Patients will receive Tislelizumab combined with Lenvatinib for 1 year in 4-6 weeks after surgery.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: TislelizumabExperimental treatment 1 intervention
Group B: Tislelizumab Combined LenvatinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Disease-free survival rate

Defined as the percent of patients without recurrence, progression or death in one year after enrollment

Time frame
1 year

Secondary outcomes

1

Objective response rate

Defined as the percent of patients with a complete response (CR) or partial response (PR) documented by the Investigator per RECIST 1.1.

Time frame
At time of surgery
2

Incidence of severe adverse events

Defined as the percent of patients with adverse events over grade 3.

Time frame
Three months after treatment
3

Major pathological response rate

Defined as the percent of patients with less than 10% visible cancer cells out of the surface expression of the total tumor area at the time of surgery

Time frame
At time of surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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