NCT05185869

SHR6390 Plus Nab-paclitaxel and Gemcitabine in Advanced/Metastatic Pancreatic Cancer

A Phase II Study of SHR6390 Plus Nab-paclitaxel and Gemcitabine in Unresectable Advanced/Metastatic Pancreatic Ductal Adenocarcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is being conducted to evaluate the efficacy, safety and tolerability of SHR6390 in combination with nab-paclitaxel and gemcitabine in first-line treatment of subjects with advanced/metastatic pancreatic cancer.

Detailed description

This is an open-label, prospective, single-center, single-arm, Simon's two-stage design phase II study for unresectable advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) subjects treated with SHR6390 plus nab-paclitaxel and gemcitabine. In this research study, the main objectives include: 1. Evaluate objective response rate in patients with pancreatic cancer receiving SHR6390 plus nab-paclitaxel and gemcitabine. 2. Assess adverse side effects associated with the combination of SHR6390 with nab-paclitaxel and gemcitabine.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	SHR6390	SHR6390, Oral Administration
DRUG	Nab-paclitaxel	Paclitaxel-albumin, Intravenous Injection
DRUG	Gemcitabine	Gemcitabine, Intravenous Injection

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-07-01
• Completion: 2025-10-01
• First posted: 2022-01-11
• Last updated: 2022-01-11

Locations

1 site across 1 country: China