NCT05346146

A Prospective, Single-arm, Exploratory Clinical Study of Sintilimab Injection in Combination With Paclitaxel (Albumin-bound) and Gemcitabine in Translational Therapy in Patients With Unresectable Locally Advanced Pancreatic Cancer.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Pancreatic cancer is a common malignant tumor of digestive tract, and its morbidity and mortality are increasing worldwide. Few clinical data have been published on immunotherapy for pancreatic cancer. This trial is a prospective, single-arm, single-center clinical study to investigate the efficacy and safety of sintilimab in combination with gemcitabine and albumin-paclitaxel conversion therapy with unresectable locally advanced pancreatic cancer.

Detailed description

This is a prospective, single-arm, single-center clinical study to investigate the efficacy and safety of sintilimab in combination with gemcitabine and albumin-paclitaxel conversion therapy with unresectable locally advanced pancreatic cancer. The primary endpoint is R0-surgery resection rate. Objective response rate, overall survival , progression-free survival, event free survival, adverse events will be recorded and analyzed, to assess the efficacy and safety of the combination treatment with sintilimab and paclitaxel (albumin-bound) and gemcitabine with metastatic pancreatic cancer. The study will also explore biomarkers that can predict efficacy, and blood and tumor samples will be collected/collected at baseline and during the trial for patients who sign informed consent, including possible tumor biopsies at baseline.

Conditions

• Unresectable Locally Advanced Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Sintilimab; Gemcitabine; Albumin-paclitaxel	Sintilimab: 200mg IV Q3W D1; Gemcitabine: 1000mg/m2 IV Q3W D1,8; Albumin-paclitaxel：125mg/m2,IV,D1,D8,Q3W

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-07-01
• Completion: 2024-07-01
• First posted: 2022-04-26
• Last updated: 2022-04-26

Locations

1 site across 1 country: China