Clinical Trials Logo

Clinical Trial Summary

The prognosis for pancreatic cancer remains dismal, with current guidelines favoring FOLFIRINOX or AG (consisting of Gemcitabine and Abraxane) as the primary chemotherapeutic option. However, research has indicated limited benefits for patients with pancreatic cancer undergoing immunotherapy using Anti-PD-1 antibodies. In this context, researchers aim to investigate the therapeutic potential of Sapropterin Dihydrochloride combined with PD-1 antibody in patients with metastatic pancreatic cancer who failed to standard treatment.


Clinical Trial Description

There is no standard treatment for patients with metastatic pancreatic cancer who failed to FOLFIRINOX or AG (consisting of Gemcitabine and Abraxane). Patients with metastatic pancreatic cancer who are unable to tolerate or have failed to respond to standard chemotherapy will be enrolled in this clinical trial. They will be administered a combination treatment of Sapropterin Dihydrochloride and PD-1 antibody. The primary endpoints of this study are objective response rate and safety. The secondary endpoints will encompass overall survival, progression-free survival, and quality of life. The study aims to enroll a total of 20 participants. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06396637
Study type Interventional
Source Sun Yat-sen University
Contact Miao-Zhen Qiu, MD
Phone 02087343351
Email qiumzh@sysucc.org.cn
Status Recruiting
Phase Phase 2
Start date April 30, 2024
Completion date April 30, 2025

See also
  Status Clinical Trial Phase
Completed NCT06006728 - Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy
Terminated NCT03213626 - Cabozantinib and Erlotinib for Patients With EGFR and c-Met Co-expressing Metastatic Pancreatic Adenocarcinoma Phase 2
Recruiting NCT05077800 - FOLFIRINOX + 9-Ing-41 + Losartan In Pancreatic Cancer Phase 2
Completed NCT01715142 - Effect on Tumor Perfusion of a Chemotherapy Combining Gemcitabine and Nab-paclitaxel (Abraxane) in Pancreatic Cancer Early Phase 1
Completed NCT02179970 - To Assess the Safety of Continuous IV Administration of Plerixafor in Patients With Advanced Pancreatic, Ovarian and Colorectal Cancers Phase 1
Completed NCT02195180 - Efficacy and Safety of L-asparaginase Encapsulated in RBC Combined With Gemcitabine or FOLFOX in 2nd Line for Progressive Metastatic Pancreatic Carcinoma Phase 2
Recruiting NCT06051851 - Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine as First-line Treatment for Advanced Metastatic Pancreatic Cancer Phase 2
Recruiting NCT03633734 - Efficacy Evaluation of Sequential Treatment With AG and Modified Folfirinox in Metastatic Pancreatic Adenocarcinoma Phase 1/Phase 2
Completed NCT03529175 - Scheduling Nab-paclitaxel With Gemcitabine Phase 2
Recruiting NCT05360264 - tailOred dRug repurposIng of dEcitabine in KRAS-dependeNt refracTory pAncreaTic cancEr Phase 2
Recruiting NCT04150042 - SHARON: A Clinical Trial for Metastatic Cancer With a BRCA or PALB2 Mutation Using Chemotherapy and Patients' Own Stem Cells Phase 1
Withdrawn NCT03127124 - QUILT-2.022 NANT-008 in Combination w/ 5-fluorouracil, Bevacizumab, Leucovorin & Oxaliplatin in Subjects With Pancreatic Cancer Phase 1/Phase 2
Not yet recruiting NCT06076837 - The Seven Trial: Exploiting the Unfolded Protein Response Phase 1
Completed NCT01053013 - Open-Label Phase 2 Efficacy Trial of Cancer Macrobeads in Patients With Treatment-Resistant Pancreatic/Colorectal Cancer Phase 2