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Tislelizumab Plus TKI as Adjuvant Therapy Versus Active Surveillance in Patients With HCC

Primary Purpose

Liver Neoplasms

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab plus tyrosine kinase inhibitor
Sponsored by
Beijing 302 Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Neoplasms focused on measuring HCC, Liver Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Eligible patients are ≥18 years, diagnosed with HCC confirmed by histopathology or cytology, with no prior targeted or immune checkpoint therapy for HCC, and have undergone curative ablation with no residual lesions according to imaging or pathological assessment. Patients are at high risk of recurrence meeting one of the following criteria: solitary tumor >2cm but ≤5cm, or multiple tumors ≤4tumors and all≤5cm; poor tumor differentiation; macrovascular invasion of the portal vein(Vp1/Vp2) ; the absence or infiltration of a tumor capsule ; AFP≥32ng/ml; HBV DNA ≥105IU/ml; history of recurrence after curative treatment; family history of tumors. Exclusion Criteria: Concurrent with other primary malignant tumors; severe coagulation dysfunction or severe thrombocytopenic purpura; There is serious infection or organ failure; have previously received targeted drugs or other PD-1 antibody therapy;

Sites / Locations

  • 302 HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tislelizumab combined with tyrosine kinase inhibitor (TKI) treatment group

No-intervention group

Arm Description

Outcomes

Primary Outcome Measures

Tumor recurrence rate (DRR)
Thoracic and abdominal enhanced MRI/CT and abdominal B-ultrasonography were performed before radical treatment, thoracic and abdominal enhanced MRI/CT and abdominal B-ultrasonography were performed after adjuvant treatment, and then thoracic and abdominal enhanced MRI/CT and abdominal B-ultrasonography were performed every 12 weeks. Tumor changes were evaluated by imaging. In addition, we will evaluate adverse events and death events: classify and grade adverse events, record the time and cause of death of patients. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2023
Last Updated
September 22, 2023
Sponsor
Beijing 302 Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06059885
Brief Title
Tislelizumab Plus TKI as Adjuvant Therapy Versus Active Surveillance in Patients With HCC
Official Title
Tislelizumab Plus Tyrosine Kinase Inhibitor (TKI) as Adjuvant Therapy Versus Active Surveillance in Patients With HCC at High Risk of Recurrence After Curative Ablation: A Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2021 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
December 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing 302 Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Background: Ablation is important radical treatment in hepatocellular carcinoma (HCC). However, the 5-year recurrence rate of HCC after ablation is up to 80%. Early and late recurrences are more likely related to tumor size, tumor multiplicity, vascular invasion, higher serum AFP level and disease etiology, etc. Some studies suggested that adjuvant immunotherapy might be associated with decreased recurrence and prolonged RFS. Adjuvant atezolizumab + bevacizumab (IMbrave 050) showed RFS improvement following curative resection or ablation. Currently, there is limited study on immunotherapy combined with TKI as postoperative adjuvant therapy for HCC. This is an open-label, prospective cohort study to compare the efficacy and safety of tislelizumab plus tyrosine kinase inhibitor (TKI) as adjuvant therapy versus active surveillance in HCC patients with high risk of recurrence after curative ablation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Neoplasms
Keywords
HCC, Liver Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tislelizumab combined with tyrosine kinase inhibitor (TKI) treatment group
Arm Type
Experimental
Arm Title
No-intervention group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Tislelizumab plus tyrosine kinase inhibitor
Intervention Description
Lenvatinib, tyrosine kinase inhibitor (TKIs)
Primary Outcome Measure Information:
Title
Tumor recurrence rate (DRR)
Description
Thoracic and abdominal enhanced MRI/CT and abdominal B-ultrasonography were performed before radical treatment, thoracic and abdominal enhanced MRI/CT and abdominal B-ultrasonography were performed after adjuvant treatment, and then thoracic and abdominal enhanced MRI/CT and abdominal B-ultrasonography were performed every 12 weeks. Tumor changes were evaluated by imaging. In addition, we will evaluate adverse events and death events: classify and grade adverse events, record the time and cause of death of patients. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eligible patients are ≥18 years, diagnosed with HCC confirmed by histopathology or cytology, with no prior targeted or immune checkpoint therapy for HCC, and have undergone curative ablation with no residual lesions according to imaging or pathological assessment. Patients are at high risk of recurrence meeting one of the following criteria: solitary tumor >2cm but ≤5cm, or multiple tumors ≤4tumors and all≤5cm; poor tumor differentiation; macrovascular invasion of the portal vein(Vp1/Vp2) ; the absence or infiltration of a tumor capsule ; AFP≥32ng/ml; HBV DNA ≥105IU/ml; history of recurrence after curative treatment; family history of tumors. Exclusion Criteria: Concurrent with other primary malignant tumors; severe coagulation dysfunction or severe thrombocytopenic purpura; There is serious infection or organ failure; have previously received targeted drugs or other PD-1 antibody therapy;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fanping Meng
Phone
010-66933219
Email
drmengfanping@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jiahe Tian
Phone
010-66933219
Email
tianjh9888@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fanping Meng
Organizational Affiliation
302 Hospital Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
302 Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fanping Meng
Email
drmengfanping@126.com

12. IPD Sharing Statement

Learn more about this trial

Tislelizumab Plus TKI as Adjuvant Therapy Versus Active Surveillance in Patients With HCC

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