Health Trials

Combined TACE, TKI/Anti-VEGF and ICIs as Conversion Therapy for Advanced Hepatocellular Carcinoma

ConditionHepatocellular Carcinoma Non-resectable
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTongji Hospital

About this trial

The aim of this study is to the efficacy, prognosis, adverse effects, and factors for predicting therapeutic effects and clinical prognosis of combined therapy of transarterial chemoembolization (TACE), Anti-VEGF antibodies or pan-target anti-angiogenic drugs, and anti-PD-1/ PD-L1 antibody for advanced hepatocellular carcinoma which initially unsuitable for the radical therapy, including resection, transplantation, or ablation.

Eligibility criteria

Qualifiers

Age ≥ 18 years old

Diagnosis of HCC is according to the American Association for the Study of Liver Diseases or European Association for the Study of the Liver guidelines of HCC management;

at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or mRESIST criteria.

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Disqualifiers

Persistent or activity (except the HBV and HCV) infection;

symptoms of congestive heart failure and uncontrolled diabetes;

uncontrolled hypertension, systolic pressure ≥ 160 mmHg or diastolic pressure ≥ 100 mmHg despite anti-hypertension medications ≤ 28 days before randomization or first dose of drug.

unstable angina,

Trial design

Treatments tested in this trial

  • TACE
  • Lenvatinib
  • Anti-PD-1 monoclonal antibody
  • Bevacizumab Biosimilar IBI305 plus sintilimab
  • Bevacizumab plus Atezolizumab
  • apatinib plus camrelizumab
  • Sorafenib
  • Donafenib
  • Regorafenib

Treatment groups

300 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Sponsors and collaborators

Tongji Hospital

Lead sponsor

Chinese Cooperative Group of Liver Cancer

Collaborator

Chen Xiao-ping Foundation for the Development of Science and Technology of Hubei Province

Collaborator

The Second Affiliated Hospital of Fujian Medical University

Collaborator

Geneplus-Beijing Co. Ltd.

Collaborator

Haplox Biotechnology Co., Ltd.

Collaborator

Source ClinicalTrials.gov