NCT04239443

Clinical Study of PD-1 Monoclonal Antibody SHR-1210 and Apatinib in Advanced NSCLC, Soft Tissue Sarcoma, and Uterine Cancer

Peripheral Circulating Blood Tumor Cells (CTC) Detection and CTC-based PD-L1 Antibody Immunofluorescence Detection to PD-1 Monoclonal Antibody SHR-1210 and Apatinib in Second-line and Back-line Treatment of Advanced NSCLC, Soft Tissue Sarcoma, Uterine Cancer Clinical Research

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Hunan Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

In this one-arm study, histologically or cytologically confirmed advanced NSCLC, uterine malignancies, and soft tissue sarcoma will be enrolled to investigate the efficacy and safety of PD-1 monoclonal antibody SHR-1210 and apatinib, at the same time, peripheral circulating blood tumor cells (CTC) detection and CTC-based PD-L1 antibody immunofluorescence detection will be performed.

Detailed description

Primary outcome: 1. Analysis of baseline levels of CTC and CTC PD-L1 and prognosis efficacy of patients: Objective remission rate (ORR), progression free survival (PFS), overall survival (OS); 2. Dynamic monitoring of CTC and CTC PD-L1 at baseline before treatment, after two cycles of treatment, and as the disease progresses. 3. Consistency analysis of PD-L1 and CTC PD-L1 expression in tissue specimens. Secondary outcome: Duration of response(DOR), Disease control rate(DCR), Safety of the combination therapy.

Conditions

• Advanced Non Small Cell Lung Cancer
• Uterine Cancer
• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	PD-1 inhibitor	Intravenous administration of SHR1210 (200mg/2weeks or 200mg/3weeks)
DRUG	Apatinib	NSCLC and Uterine cancer will be given oral of Apatinib (250mg/d), soft tissue sarcoma will be given oral of Apatinib (500mg/d).

Timeline

• Start date: 2019-01-30
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2020-01-27
• Last updated: 2020-01-27

Locations

1 site across 1 country: China