Abstract 1031TiP
Background
To date, Transarterial Chemoembolization (TACE) and Arterial Infusion Chemotherapy are deemed as two major methods of interventional therapy being equipped with the advantages of small trauma, easy operation, good prognosis and swift operation speed. It is indicated by emerging preclinical and clinical data that the vascular intervention therapy can induce a peripheral anti-tumor immune response, which will impact the immune microenvironment, increase the expression of PD-L1 in tumor cells, and augment the effects of immune checkpoint inhibitors as well. Camrelizumab, an anti-PD-1 monoclonal antibody, in combination with Apatinib, a small molecule tyrosine kinase inhibitor, has been demonstrated achieving clinical benefits in multiple advanced solid tumors. Considering diverse anti-tumor mechanisms, the combination of vascular intervention with immune checkpoint inhibitors and tyrosine kinase inhibitor may potentially become a therapeutic strategy in a variety of solid tumors. As a consequence, this study aims to explore the effectiveness and safety of vascular intervention combined with Camrelizumab and Apatinib for patients with inoperable solid tumors.
Trial design
In this single-arm, prospective, phase II study, 30 patients with inoperable solid tumors are enrolled. Eligible patients have measurable tumor lesions, ECOG performance score of 0-2, aged 18- 75 years and the expected overall survival ≥ 3 months. Each patient receives Camrelizumab (200 mg, iv, for 2-4 times) accompanied by vascular intervention (for 2-4 times). Treatments are repeated every 28 days last for 4 cycles, followed by maintenance with Camrelizumab (200 mg, iv, q3w) and Apatinib (250 mg, QD). The treatment regimens will continue until the disease progression, unacceptable toxicity or withdrawal of consent. The primary endpoints are safety and progress-free survival assessed by investigator according to RECIST v1.1, while the secondary endpoints contain objective response rate, disease control rate and overall survival.
Clinical trial identification
ChiCTR2000033932.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.