Advanced Pancreatic Cancer Clinical Trial
Official title:
Efficacy and Safety of Nab-Paclitaxel Plus S-1 in the First-line Treatment of Advanced Pancreatic Cancer: A Pilot Single Arm Phase II Study
Pancreatic cancer is a common malignancy of digestive system with gradually increasing incidence, is the fourth and seventh leading cause of cancer-related mortality in the world (1) and China (2) according to the statistics in 2014. The vast majority of patients were confirmed as locally advanced or distantly metastatic disease at diagnosis with an estimated five-year survival rate of 4% (3) due to occlusive development and rapid progress. Advanced pancreatic cancer is characterized by poor prognosis.
Gemcitabine has been approved as the standard chemotherapy for advanced pancreatic cancer since 1996, but the efficacy is extremely limited by a response rate of 6-8%, and median survival of 5.5-7 months. However, Gemcitabine-based combination treatments fail to transcend GEM monotherapy on overall survival, including GEM + 5-Fu [10], GEM + Oxaliplatin[11], and GEM + Irinotecan [12] and GEM + Cisplatin [13] (7-8) . Until 2011, Conroy et al.[15] reported that FOLFIRINOX solutions significantly improved ORR (31.6% vs 9%, P=0.0008), PFS (6.4 vs. 3.3 months, P<0.0001) and OS (11.1 vs. 6.8 months, P<0.001) than GEM single-agent, but the significant increase of grade 3/4 adverse reactions, to some extent, limited its wide application. Therefore, it is necessary to continue to explore effective and safe chemotherapy of advanced pancreatic cancer. Nab-Paclitaxel was approved by FDA for advanced pancreatic cancer in September 2013. S-1 has demonstrated potential value in the treatment of advanced pancreatic cancer as a new compound oral 5-FU(4-5) and has been approved for pancreatic cancer treatment in Japan. We conducted a single arm, prospective, phase II study in our center on the first-line treatment of advanced pancreatic cancer with nab-Paclitaxel and S-1 to investigate the efficacy and safety of the combination regimen. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05028933 -
IMC001 for Clinical Research on Advanced Digestive System Malignancies
|
Phase 1 | |
Not yet recruiting |
NCT03662035 -
Apatinib Combined With S-1 in the Second-line Treatment of Advanced Pancreatic Cancer
|
Phase 2 | |
Recruiting |
NCT05085548 -
ProAgio in Previously Treated Advanced Pancreatic Cancer and Other Solid Tumor Malignancies
|
Phase 1 | |
Recruiting |
NCT06111274 -
A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04137536 -
A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer
|
Phase 1 | |
Completed |
NCT04617067 -
Paricalcitol Trial: Phase II, Open Label Clinical Trial of Paricalcitol in Combination With Gemcitabine/ Nab-Paclitaxel Therapy in Advanced Pancreatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04469556 -
Pancreatic Adenocarcinoma Signature Stratification for Treatment
|
Phase 2 | |
Recruiting |
NCT04104672 -
A Study to Evaluate the Safety and Tolerability of AB680 in Participants With Gastrointestinal Malignancies
|
Phase 1 | |
Not yet recruiting |
NCT05100329 -
A Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced Pancreatic Cancer
|
Phase 2 | |
Completed |
NCT02101580 -
Ph 1B Trial With ADI-PEG 20 Plus Nab-Paclitaxel and Gemcitabine in Subjects With Pancreatic Cancer
|
Phase 1 | |
Not yet recruiting |
NCT06329947 -
A Phase II Study of Surufatinib Combined With Camrelizumab and mFOLFOX6 as Second-line Treatment for Advanced PRAD
|
Phase 2 | |
Recruiting |
NCT02135822 -
Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Advanced Pancreatic Cancer
|
Phase 2 | |
Recruiting |
NCT04803851 -
Anlotinib Plus Anti-PD-1 Antibody AK105 for Advanced Pancreatic Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT05162118 -
Clinical Study of VG161 in Combination With Nivolumab in Subjects With Advanced Pancreatic Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT04643405 -
APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT03889795 -
Phase IB Metformin, Digoxin, Simvastatin in Solid Tumors
|
Phase 1 | |
Completed |
NCT01303172 -
A Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer
|
Phase 2 | |
Not yet recruiting |
NCT06422156 -
SBRT Combined With Nimotuzumab and Mono-chemotherapy in Locally Advanced Pancreatic Cancer
|
Phase 2 | |
Recruiting |
NCT04931381 -
Organoid-Guided Chemotherapy for Advanced Pancreatic Cancer
|
Phase 3 | |
Recruiting |
NCT04482257 -
Bioequivalence Study of Irinotecan Liposome Injection in Chinese Advanced Pancreatic Cancer.
|
Phase 1 |