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

NCT04615143 | Recruiting Phase 2 DMC

• 1 other identifier: RHCC2020
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Recurrent Hepatocellular Carcinoma

Keywords

recurrent hepatocellular carcinoma; neoadjuvant treatment; immune therapy

Outcome Measures

Primary Outcomes (1)

• Disease-free survival rate

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

  1 year

Secondary Outcomes (3)

• Objective response rate

  At time of surgery

• Incidence of severe adverse events

  Three months after treatment

• Major pathological response rate

  At time of surgery

Study Arms (2)

Tislelizumab

EXPERIMENTAL

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

Drug: Tislelizumab

Tislelizumab Combined Lenvatinib

EXPERIMENTAL

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

Drug: Tislelizumab combined with Levatinib

Interventions

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

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.

Tislelizumab Combined Lenvatinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);
• Abnormal organ function

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 4, 2020
• Study Start: December 1, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)