NCT05171309

Camrelizumab in Combination With Apatinib Plus NK Cell for Advanced HCC

Camrelizumab in Combination With Apatinib Plus NK Cell in Patients With Advanced Hepatocellular Carcinoma (CAN): A First-line, Phase-II, Single-arm Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Camrelizumab in combination with apatinib plus NK cell in patients with advanced hepatocellular carcinoma.

Detailed description

The IMbrave150 study has demonstrated a new regimen to be superior to sorafenib by reducing 42% of death risk, making "T+A" strategy to be the first-line treatment for patients with advanced HCC. Meanwhile, the RESCUE research showed that combined camrelizumab with apatinib has promising objective response rate (ORR=34.3%) and disease control rate (DCR=77.1%) in advanced HCC patients as first-line treatment. Nevertheless, the above researches both show only a fraction of patients benefits from the anti-PD-1/PD-L1 in combination with antiangiogenic therapy. Therefore, it's urgently needed to explore better combinational strategies with other treatments to enhance the efficacy of anti-PD-1 in combination with antiangiogenic therapy. Recently, Pembrolizumab plus allogeneic NK cells have been proved to be effective in advanced non-small cell lung cancer patients. However, there is no study available now analyzing the efficacy and safety of Camrelizumab in combination with apatinib plus NK cell in patients with advanced hepatocellular carcinoma.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Apatinib	250 mg once daily (QD) oral dosing.
DRUG	Camrelizumab	200 mg intravenously every 2 weeks.
DRUG	NK cell	Cord blood derived NK cells 4 cycles, one cycle is defined as: total cells ≥1×109 per time, continuous intravenous infusion for 2 days every 14±2 days

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2021-12-28
• Last updated: 2021-12-28

Locations

1 site across 1 country: China