NCT06472037

AG Combined With Cadonilimab Sequential Short-course Radiotherapy in the Treatment of Locally aPDAC

A Prospective, Single-arm, Phase II Study Assessing the Efficacy of Gemcitabine, Nab-paclitaxel, and Cadonilimab With Sequential Short-course Radiotherapy in Locally Advanced Pancreatic Ductal Adenocarcinoma Patients.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A prospective, single-arm, exploratory phase II clinical study evaluating the efficacy of Gemcitabine and Nab-palitaxe combined with Cadonilimab sequential short-course radiotherapy in the treatment of patients with locally advanced pancreatic ductal adenocarcinoma.

Detailed description

This trial is a prospective, single-arm, single-center, phase II clinical study aimed at investigating the efficacy and safety of Cadonilimab combined with Gemcitabine and Nab-palitaxe in short-course radiotherapy neoadjuvant treatment for locally advanced pancreatic ductal adenocarcinoma patients. Patients will receive Gemcitabine and Nab-palitaxe combined with Cadonilimab treatment for one cycle, followed by sequential short-course radiotherapy and then Gemcitabine and Nab-palitaxe combined with Cadonilimab treatment. If feasible, radical surgery will be performed to assess efficacy. A total of 8 cycles of chemotherapy will be administered, followed by Cadonilimab maintenance for up to 1 year.

Conditions

• Locally Advanced Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Cadonilimab	10mg/kg，IV，D1，Q3W
DRUG	Gemcitabine	1000mg/m2，IV，D1、D8、D15，Q4W
DRUG	Nab-Paclitaxel	125mg/m2，IV，D1、D8、D15，Q4W

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-05-01
• Completion: 2025-07-01
• First posted: 2024-06-24
• Last updated: 2024-12-04

Locations

1 site across 1 country: China