NCT05099848

A Trial of Conversion Treatment of HAIC Combined With Camrelizumab and Apatinib for Unresected Hepatocellular Carcinoma

A Single-arm Exploratory Clinical Study of Conversion Treatment of Hepatic Arterial Infusion Chemotherapy Combined With Camrelizumab and Apatinib for Unresected Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study is being conducted to evaluate the efficacy and safety of conversion treatment of Hepatic Arterial Infusion Chemotherapy combined with Camrelizumab and Apatinib for unresected hepatocellular carcinoma.

Detailed description

A single-arm exploratory clinical study of conversion treatment of Hepatic Arterial Infusion Chemotherapy combined with Camrelizumab and Apatinib. After screening, subjects who meet the requirements for entry and exclusion signed the informed consent, received carrelizumab combined with apatinib and HAIC for conversion therapy, and After received 2-8 cycles (1 treatment cycle every 21 days) of HAIC combined camrelizumab and apatinib treatment, assess whether the subjects can undergo surgery every 2 cycles during the period: patients who are assessed as being able to undergo radical surgical resection receive elective radical resection surgery, and PD1 antibody should be stopped before surgery For 1 month, TKI drugs will be discontinued for 2-6 weeks; subjects who are assessed as not undergoing radical surgical resection will end this treatment plan. After leaving the group, they can receive any treatment according to the doctor's instructions and continue to follow up until the disease progresses and cannot be tolerated Toxic side effects, withdrawal of informed consent.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Camrelizumab	Procedure: 1. Taking Apatinib-Mesylate Tablets (250 mg/tablet) orally on the 1st day 30minutes after meals, once a day, for continuous medication. 2. On the 2nd day of treatment, intravenous infusion of Camrelizumab 200mg every 3 weeks. 3. On the 3rd to 4th day of treatment, HAIC was conducted through a catheter intubated into the tumor feeding artery under DSA guidance with the following chemotherapeutic drugs (mFOLFOX, oxaliplatin 85 mg/m2 in 0-2 hours, folinic acid 400 mg/m2 in 2-3 hours, 5-FU 2500 mg/m2 46 hours) pumped into the tumor artery. The HAIC is repeated every 3 weeks. The cumulative maximum sessions of HAIC is up to 8 times. The cumulative maximum drug use period is up to 8 cycles. Patient will be administratied radical resection if possible during treatment. The patient is concurrent on medication until the treatment discontinuation criteria specified in the protocol appear.

Timeline

• Start date: 2021-03-17
• Primary completion: 2024-06-30
• Completion: 2024-12-31
• First posted: 2021-10-29
• Last updated: 2023-08-15

Locations

1 site across 1 country: China