NCT06584227

Adebrelimab and Chidamide for Pancreatic Cancer

A Single-Arm, Multicenter, Open, Phase II Clinical Study of Adebrelimab and Chidamide in Combination With Gemcitabine and S1 for the First-Line Treatment of Locally Advanced or Metastatic Pancreatic Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Liu Xiufeng · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Pancreatic cancer is a kind of digestive system tumor with high malignant degree and poor prognosis. Most patients with pancreatic cancer are locally advanced or have distant metastases at the time of diagnosis, so it is extremely important to find effective drugs to control tumor metastasis. The primary treatment regimen for advanced pancreatic cancer remains chemotherapy, which results in a median survival time of only 8 to 12 months. Therefore, there is an urgent need to explore new combination therapies to extend survival. Therefore, this study aims to evaluate the efficacy and safety of Adebrelimab and Chidamide in Combination with Gemcitabine and S1 as first-line treatment for locally advanced or metastatic pancreatic cancer.

Detailed description

Pancreatic cancer is a kind of digestive system tumor with high malignant degree and poor prognosis. Most patients with pancreatic cancer are locally advanced or have distant metastases at the time of diagnosis, so it is extremely important to find effective drugs to control tumor metastasis. There are few approved first-line treatment options for metastatic pancreatic cancer. The FOLFIRINOX regimen (Irinotecan combined with Oxaliplatin and 5FU/LV) is recommended as a first-line treatment for patients with good overall performance status (ECOG 0-1), with a median overall survival of approximately 11.1 months. For patients with ECOG 0-2, the combination of Gemcitabine and Albumin-bound Paclitaxel is an option for first-line chemotherapy, with a median survival of 8.5 months. Single-agent Gemcitabine or S-1 is the standard first-line treatment for patients with poor overall performance status, resulting in a median survival of approximately 6 to 9 months. Therefore, for pancreatic cancer patients, the efficacy of existing first-line treatment regimens has reached a bottleneck, highlighting the urgent need to explore new first-line combination therapy options. Immunotherapy has demonstrated significant advantages in solid tumors, however, its application in pancreatic ductal adenocarcinoma (PDAC) has been disappointing to date. Although several promising preclinical studies have been conducted, translating these findings into clinical research remains challenging, likely due to the complex immunosuppressive tumor microenvironment of PDAC. Therefore, this study aims to evaluate the efficacy and safety of Adebrelimab and Chidamide in Combination with Gemcitabine and S1 as first-line treatment for locally advanced or metastatic pancreatic cancer.

Conditions

• Pancreatic Cancer, Adult

Interventions

Type	Name	Description
DRUG	Adebrelimab and Chidamide Combined with Gemcitabine and S1	Chidamide：20mg，po，biw，（d8、11、15、18）； Adebrelimab: 1200mg，d8，q3w； Gemcitabine：800-1000mg/m2，bid，d1、d8，q3w； S1：40mg/50mg，bid，d1-14，q3w.

Timeline

• Start date: 2024-09-10
• Primary completion: 2026-07-10
• Completion: 2027-05-10
• First posted: 2024-09-04
• Last updated: 2025-12-08

Locations

1 site across 1 country: China