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

NCT06059885 | Unknown Phase 2

• 1 other identifier: ChiECRCT20210555
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Neoplasms

Keywords

HCC; Liver Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  52 weeks

Study Arms (2)

Tislelizumab combined with tyrosine kinase inhibitor (TKI) treatment group

EXPERIMENTAL

Drug: Tislelizumab plus tyrosine kinase inhibitor

No-intervention group

NO INTERVENTION

Interventions

Tislelizumab plus tyrosine kinase inhibitor DRUG

Lenvatinib, tyrosine kinase inhibitor (TKIs)

Tislelizumab combined with tyrosine kinase inhibitor (TKI) treatment group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Study Sites (1)

302 Hospital

Beijing, Beijing Municipality, 100039, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Interventions

tislelizumab; Tyrosine Kinase Inhibitors

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Fanping Meng

  302 Hospital Beijing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fanping Meng

CONTACT

010-66933219; drmengfanping@126.com

Jiahe Tian

CONTACT

010-66933219; tianjh9888@163.com

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: The Fifth Medical Centre of the General Hospital of PLA

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 29, 2023
• Study Start: December 22, 2021
• Primary Completion: March 31, 2025
• Study Completion: December 20, 2025
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

CN (1)