Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584227
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
Adebrelimab and Chidamide for Pancreatic Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACPC
Brief 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 5FULV is recommended as a first-line treatment for patients with good overall performance status ECOG 0-1 with a median overall survival of approximately 111 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 85 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None