TACE Plus Camrelizumab and Apatinib for Unresectable Hepatocellular Carcinoma (NCT06485466) | Clinical Trial Compass
RecruitingPhase 3
TACE Plus Camrelizumab and Apatinib for Unresectable Hepatocellular Carcinoma
China101 participantsStarted 2024-08-10
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Initial treatment of hepatocellular carcinoma.
✓. According to mRECIST, there is at least one measurable lesion.
✓. Child Pugh score ≤ 7.
✓. Participant has sufficient organ and marrow functions.
Exclusion criteria
✕. Fibrolamellar carcinoma, sarcomatoid carcinoma, cholangiocarcinoma and other components previously confirmed by histology / cytology.
✕. History of hepatic encephalopathy or liver transplantation.
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What they're measuring
1
progression free survival (PFS)
Timeframe: Up to 24 months, from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
. 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.
✕. Received local treatment (ablation therapy, TACE), surgery resection and radiotherapy for liver cancer before the first administration.
✕. Have received systemic chemotherapy, targeted therapy or immunotherapy
✕. There is a significant decrease in white blood cells and platelets in peripheral blood, severe coagulation dysfunction and can not be corrected：the neutrophil\<1.5×109/L, PLT\<50×109/L. The INR\>2.3
✕. Acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV-DNA) \> 10\^6 copies / ml; hepatitis C virus (HCV-RNA) \> 10\^3 copies / ml; HBsAg and anti HCV antibody were positive at the same time.