NCT04181645

SHR- 1210 Combined With Paclitaxel (Albumin Bound) and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single center, non-randomized, phase I trial to evaluate safety and efficacy of using the combination treatment of SHR-1210 with Paclitaxel-albumin and gemcitabine of metastatic PDAC.

Detailed description

This is an open-label, single center, non-randomized, phase I trial to evaluate safety and efficacy of using the combination treatment of SHR-1210 with Paclitaxel-albumin and gemcitabine of metastatic PDAC. PD-1 antibody SHR-1210 is a humanized monoclonal antibody, and the heavy chain is immunoglobulin G4 (IgG4), the light chain is immunoglobulin κ (IgK). SHR-1210 specifically binds to PD-1 and blocks the interaction of PD-1 with its ligand (PD-L1), allowing T cells to recover against tumor immune responses. The safety of SHR-1210 will be assessed by ongoing reviews of clinical laboratory tests, Eastern Cooperative Oncology Group (ECOG) performance status, physical examination, electrocardiogram (ECG), and adverse events. Evaluations of immune safety will also be conducted (immune-related adverse events (AEs), or labs of autoimmune sera, inflammatory events, and immunogenicity). Safety evaluations (both clinical and laboratory) are performed at baseline, before each study treatment, and throughout the study. Tumor response will be assessed by radiographic examination in screening visit and every 2 cycles after first dose.

Conditions

• Pancreatic Cancer Stage IV

Interventions

Type	Name	Description
DRUG	Biological: SHR-1210 Drug: Gemcitabine Drug:Paclitaxel-albumin	SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. Gemcitabine Other Name: Gemcitabine Hydrochloride for Injection Paclitaxel-albumin Other Name: Paclitaxel-albumin Injection

Timeline

• Start date: 2019-06-29
• Primary completion: 2021-12-01
• Completion: 2023-05-01
• First posted: 2019-11-29
• Last updated: 2024-04-03

Locations

1 site across 1 country: China