TACE Plus Camrelizumab and Apatinib for Unresectable Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGuohui Xu
About this trial
Hepatocellular carcinoma (HCC) is the sixth most common cancer and the third most common cause of cancer-related death worldwide. The majority of patients with HCC are diagnosed as intermediate or advanced stage disease, and not eligible for curative treatments including transplantation, resection, and ablation. Transarterial chemoembolization (TACE) is recommended as first-line treatment for patients with intermediate-stage HCC, while it is also widely used in the unresectable HCC.
The clinical efficacy and safety in advanced HCC patients of camrelizumab plus apatinib were reported in phase 3 trial (CARES-310). Camrelizumab plus apatinib with a median progression-free survival of 5.7 months and a median overall survival of 22.1 months in advanced HCC.
This study is randomized, open-label, multicenter controlled trial; which was focused in initial BCLC-B/C HCC patients. This study aimed to compare the efficacy and safety of TACE plus programmed death-1 inhibitor (camrelizumab), and anti-angiogenic therapy (apatinib) with camrelizumab plus apatinib.
Eligibility criteria
Qualifiers
Histopathologically or clinically confirmed hepatocellular carcinoma
18-80 years old.
Performance status (PS) ≤ 1 (ECOG scale).
Barcelona clinical liver cancer (BCLC) stage B or stage C.
Disqualifiers
Fibrolamellar carcinoma, sarcomatoid carcinoma, cholangiocarcinoma and other components previously confirmed by histology / cytology.
History of hepatic encephalopathy or liver transplantation.
Pleural effusion, ascites and pericardial effusion with clinical symptoms requiring drainage.
Tumor burden≥70%, diffuse liver cancer or tumor is not suitable for mRECIST standard evaluation.
Trial design
Treatments tested in this trial
- TACE plus camrelizumab and apatinib
- Camrelizumab and apatinib
Treatment groups
101 Participants
are divided into 2 treatment groupsSponsors and collaborators
Guohui Xu
Lead sponsor
Sichuan Cancer Hospital and Research Institute
Sponsor institution
Source ClinicalTrials.gov