NCT03755115

SHR-1210 Combined With Epirubicin in the Treatment of Extensive Disease Small Cell Lung Cancer

Clinical Study of PD-1 Monoclonal Antibody SHR-1210 Combined With Epirubicin in the Treatment of Extensive Small Cell Lung Cancer After First-line Treatment Failure

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Patients with extensive disease SCLC after failure of first-line treatment were enrolled with SHR-1210 and epirubicin for 3 cycles to evaluate initial efficacy

Detailed description

Small cell lung cancer is a neuroendocrine tumor with strong invasiveness, rapid growth rate and early metastasis in lung cancer. The systemic chemotherapy response rate is high in a wide range of patients, but it is easy to resist drug recurrence, which brings certain difficulties to clinical treatment. The signaling pathway activated by programmed cell death receptor 1 (PD-1) and its ligand (programmed death-ligand 1, PDL1) is a hotspot in recent years and has brought good news to cancer patients. However, PD1 inhibitors are only about 13% effective in treating lung cancer patients. Epirubicin is a classic drug that activates the immunogenicity of tumor tissues, induces tumor immunogenic death, and releases some marker proteins such as CRT, HMGB1, HSP and so on. These two drugs combine to enhance the anti-tumor effect of the human immune system.The investigators designed the study to explore the possibility of apatinib as the Second-line Therapy in ED-SCLC.

Conditions

• Small Cell Lung Cancer Extensive Stage

Interventions

Type	Name	Description
DRUG	Epirubicin plus SHR1210	First intravenous injection of epirubicin injection, D1,30mg/m\^2 Then intravenous administration with SHR-1210,D1, a fixed dose of 200mg, 30min per infusion, Q2W. The total dose of epirubicin is 360 mg/m\^2.next SHR-1210 single drug maintenance .Until to secdonary disease progression or intolerance side effects.Evaluate efficacy every 3 cycles.

Timeline

• Start date: 2019-02-01
• Primary completion: 2019-10-28
• Completion: 2020-05-31
• First posted: 2018-11-27
• Last updated: 2019-01-16

Locations

1 site across 1 country: China