Health Trials

Combined HAIC, TKI/Anti-VEGF and ICIs as Conversion Therapy for Unresectable Hepatocellular Carcinoma

ConditionHepatocellular Carcinoma Non-resectable
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZe-yang Ding, MD

About this trial

This study is conducted to evaluate the efficacy, prognosis, adverse effects, and factors for predicting therapeutic effects and clinical prognosis of combined therapy of hepatic artery infusion chemotherapy (HAIC), tyrosine kinase inhibitor/ anti-VEGF antibody, and anti-PD-1/ PD-L1 antibody for advanced hepatocellular carcinoma which initially unsuitable for the radical therapy, including resection, transplantation, or ablation. Factors are collected in preoperative routine blood examination, preoperative radiological imaging and pathological examination.

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

Prior invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, lobular or ductal carcinoma in situ of the breast that has been surgically cured

Trial design

Treatments tested in this trial

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

Treatment groups

300 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Sponsors and collaborators

Ze-yang Ding, MD

Lead sponsor

Tongji Hospital

Sponsor institution

Chinese Cooperative Group of Liver Cancer

Collaborator

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

Collaborator

Haplox Biotechnology Co., Ltd.

Collaborator

Geneplus-Beijing Co. Ltd.

Collaborator

The Second Affiliated Hospital of Fujian Medical University

Collaborator

Source ClinicalTrials.gov