Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454448
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-06
Brief Title:
Phase IbII Clinical Study of Adebrelimab in Combination With Decitabine Albumin-bound Paclitaxel and Gemcitabine for the First-line Treatment of Metastatic Pancreatic Cancer
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
Phase IbII Clinical Study of Adebrelimab in Combination With Decitabine Albumin-bound Paclitaxel and Gemcitabine for the First-line Treatment of Metastatic Pancreatic Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pancreatic cancer is a kind of digestive system tumor with extremely high malignancy and poor prognosis Although the trend of benefit from immunotherapy in combination with chemotherapy is currently reflected in several exploratory studies the overall efficacy is still relatively limited
Dysregulation of epigenetic mechanisms which is common in cancer leads to down-regulation of genes involved in tumor antigen processing or presentation resulting in immune evasion and thus affecting the efficacy of immunotherapy Epigenetic inhibitors may enhance the efficacy of immunotherapy by enhancing antigenicity and presentation of tumor-associated antigens reprogramming the tumor microenvironment to counteract immunosuppression and reversing cytotoxic T-cell depletion Thus decitabine-promoted immunotherapeutic sensitization is a potential therapeutic avenue for mPDAC patients that warrants further exploration in clinical trials Taking into account the characteristics of pancreatic cancer immunophenotype exploring combination therapy regimens that enhance anti-tumor immune response and improve the efficacy of immunotherapy has become an urgent clinical problem
This study is a prospective single-arm single-center phase IBII clinical study exploring the efficacy and safety of adebrelimab in combination with decitabine albumin-bound paclitaxel and gemcitabine in the first-line treatment of metastatic pancreatic cancer The primary study endpoints are DLT RP2D and ORR Secondary study endpoints are OS PFS DCR DoR and safety
Dysregulation of epigenetic mechanisms which is common in cancer leads to down-regulation of genes involved in tumor antigen processing or presentation resulting in immune evasion and thus affecting the efficacy of immunotherapy Epigenetic inhibitors may enhance the efficacy of immunotherapy by enhancing antigenicity and presentation of tumor-associated antigens reprogramming the tumor microenvironment to counteract immunosuppression and reversing cytotoxic T-cell depletion Thus decitabine-promoted immunotherapeutic sensitization is a potential therapeutic avenue for mPDAC patients that warrants further exploration in clinical trials Taking into account the characteristics of pancreatic cancer immunophenotype exploring combination therapy regimens that enhance anti-tumor immune response and improve the efficacy of immunotherapy has become an urgent clinical problem
This study is a prospective single-arm single-center phase IBII clinical study exploring the efficacy and safety of adebrelimab in combination with decitabine albumin-bound paclitaxel and gemcitabine in the first-line treatment of metastatic pancreatic cancer The primary study endpoints are DLT RP2D and ORR Secondary study endpoints are OS PFS DCR DoR and safety
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None