NCT05277675

Brief Summary

  1. 1.To compare systemic neoadjuvant therapy (combination of immune checkpoint inhibitors and anti-angiogenic drugs (short for "targeted-immune therapy") combined with radiofrequency ablation (RFA) and RFA alone in the treatment of recurrent hepatocellular carcinoma(HCC) in 1-year recurrence-free survival (RFS) and overall survival (OS)
  2. 2.To evaluate the clinical value of systemic neoadjuvant therapy (i.e. immune checkpoint inhibitors and targeted therapy) combined with RFA in the treatment of recurrent HCC, as well as the safety and efficacy of this strategy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

March 14, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

February 27, 2022

Last Update Submit

March 11, 2022

Conditions

Hepatocellular Carcinoma Recurrent

Keywords

immune checkpoint inhibitorstargeted therapyneoadjuvant therapyradiofrequency ablationhepatocellular carcinomarecurrence

Outcome Measures

Primary Outcomes (2)

  • 1-year recurrence-free survival

    Evaluated by hepatic imaging examination (contrast-enhanced US/CT/MRI) at early stage combined with AFP and PIVKA-Ⅱtests.

    1 year after treatment

  • 1-year overall survival

    Evaluated by hepatic imaging examination (contrast-enhanced US/CT/MRI) at early stage combined with AFP and PIVKA-Ⅱtests.

    1 year after treatment

Secondary Outcomes (2)

  • procedure related complications

    up to 1 year.

  • immune-related adverse events

    up to 1 year.

Study Arms (2)

Neoadjuvant therapy+ RFA

EXPERIMENTAL

After confirmation of HCC recurrence by imaging exam, subjects will receive neoadjuvant therapy (immune checkpoint inhibitors + targeted therapy) and then RFA

Drug: Tislelizumab/Sintilimab+Lenvatinib/BevacizumabProcedure: RFA

RFA alone

ACTIVE COMPARATOR

After confirmation of HCC recurrence by imaging exam, subjects will receive RFA treatment only.

Procedure: RFA

Interventions

Tislelizumab/Sintilimab+Lenvatinib/BevacizumabDRUG

Immune checkpoint inhibitor (tislelizumab/sintilimab) combined with anti-angiogenic drugs (lenvatinib/bevacizumab) used as neoadjuvant therapy

Neoadjuvant therapy+ RFA
RFAPROCEDURE

RFA will be performed in a percutaneous way guided contrast enhanced ultrasound.

Neoadjuvant therapy+ RFARFA alone

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Research subjects understand the research content and significance, and provide the written informed consent;
  • age 18 - 75 years and gender is not limited;
  • a history of liver resection or RFA for HCC which was clinically or pathologically diagnosed according to the standard of the American Association for the Study of Liver Diseases; the number of lesions ≤ 3, the largest lesion ≤ 3 cm, as demonstrated on by contrast enhanced CT/MRI;
  • Patients who are unable or unwilling to undergo liver resection, and have not received other anti-tumor therapies before detection of the recurrence;
  • Child Pugh A (≤ 7 points), no pleural ascites and hepatic encephalopathy requiring treatment; Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
  • Within 7 days before enrollment, have sufficient liver and kidney function, suitable laboratory indicators (untreated): hemoglobin (HGB) ≥ 9.0 g/dl, neutrophils ≥ 1,500/mm3, PLT ≥ 50×109/L, serum ALB ≥ 28 g/L, TBIL \< 50 umol/L, ALT, AST \< 5 times the upper limit of normal, Bun, Cr \< 1.5 times the upper limit of normal, INR \< 1.7 or prolonged PT \< 4 s;
  • Consent to take the immune checkpoint inhibitor and molecular-targeted drugs;
  • No other diseases affecting RFA treatment and targeted therapy combining with immune checkpoint inhibitors.

You may not qualify if:

  • Patients who have a history of immune checkpoint inhibitor or targeted therapy;
  • Tumor invades the branch or trunk of portal vein;
  • Patients with extrahepatic metastasis;
  • Patients who have an active autoimmune disease or a history of autoimmune disease, hyperthyroidism or hypothyroidism, asthma requiring bronchodilator treatment.
  • Patients who have significant cardiovascular disease (heart failure grade Ⅲ or higher as defined by the New York Heart Association), myocardial infarction, unstable arrhythmia, unstable angina pectoris that occurred within 3 months before treatment;
  • Patients who have a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, or an evidence of active pneumonia during chest CT scan screening;
  • Patients who have received allogeneic stem cell or solid organ transplantation (including liver transplantation);
  • Patients who have taken any anti-tumor Chinese herbal medicine within 7 days before enrollment;
  • Patients who have any other diseases, metabolic disorders, abnormal results of physical examination or laboratory tests, which may lead to contraindication to the use of the experimental drugs, or affect the reliability of the research results, or leave the patient at high risk of treatment complications, or affect patient compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of hepatobiliary surgery,Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, HepatocellularRecurrence

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Kai Feng, MD,PhD

CONTACT

+86-13228683383fengkai7688@hotmail.com

Kuansheng Ma, MD,PhD

CONTACT

+86-15213249505kuanshengma@outlook.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 27, 2022

First Posted

March 14, 2022

Study Start

November 1, 2021

Primary Completion

November 1, 2022

Study Completion

October 30, 2023

Last Updated

March 14, 2022

Record last verified: 2022-03

Locations

CN(1)