NCT04850040

A Neoadjuvant Hepatocellular Carcinoma Study of Camrelizumab in Combination With Apatinib and Oxaliplatin

An Efficacy and Safety Study of Camrelizumab in Combination With Apatinib Mesylate and Oxaliplatin for Neoadjuvant Therapy in Patients With Potentially Resectable Hepatocellular Carcinoma.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, single-center, clinical research.This trial will explore the efficacy and safety of Camrelizumab in combination with Apatinib Mesylate and Oxaliplatin for neoadjuvant therapy in patients with potentially resectable hepatocellular carcinoma.

Detailed description

There is no high-level evidence on the efficacy of systemic therapy in neoadjuvant studies for hepatocellular carcinoma, and guidelines recommend TACE as the treatment of choice. Given that combination therapies such as immunotherapy in combination with targeted therapy and immunotherapy in combination with chemotherapy have achieved good efficacy in systemic therapy for liver cancer, this study is intended to explore the efficacy of TACE. In this study, we propose to explore the use of kareliozumab in combination with apatinib and oxaliplatin for the treatment of hepatocellular carcinoma. In this study, we propose to investigate the efficacy and safety of neoadjuvant therapy with kalilizumab in combination with apatinib and oxaliplatin in patients with potentially resectable hepatocellular liver cancer.

Conditions

• Hepatocellular Carcinoma Resectable

Interventions

Type	Name	Description
DRUG	Apatinib Mesylate	250 mg, oral every other day. Approximately half an hour after a meal (the daily dose should be taken at the same time as possible) with warm boiled water.
DRUG	Camrelizumab	200 mg, 30 minutes intravenous drip (overall dosing time no shorter than 20 minutes and no longer than 60 minutes, including tube flush time) once every 2 weeks, with the first dose administered concurrently with Apatinib Mesylate Tablets.
DRUG	Oxaliplatin	85 mg/m2, once every 2 weeks, to be administered half an hour after Camrelizumab injection.

Timeline

• Start date: 2021-05-06
• Primary completion: 2022-12-31
• Completion: 2024-12-31
• First posted: 2021-04-20
• Last updated: 2021-04-20