Pancreatic Cancer Clinical Trials

Find Pancreatic Cancer Clinical Trials Near You

Bortezomib Combined with PD-1 MAb and MFOLFIRINOX for First-line Treatment of Metastatic Pancreatic Cancer:An Exploratory Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This is an single-center, prospective, open-label clinical trial, to explore the safty and efficacy of combination of Bortezomib, Sindilizumab, and mFOLFIRINOX Chemotherapy (oxaliplatin, fluorouracil, irinotecan, leucovorin) in metastatic pancreatic cancer

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC).

• Recurrent disease or metastatic disease (such as liver, peritoneum, lung) evaluated by abdominal contrast-enhanced CT, MRI, and chest CT. PET/CT or other imaging examinations would be used if necessary.

• Never receive any systematic treatment or Progression after fisrt line Gemcitabine base chemotherapy

• ECOG score 0 or 1.

• Serum creatinine level is normal, and serum total bilirubin level is less than 1.5 x ULN.

• ALT and AST are less than 2 x ULN.

• Signed informed consent.

Locations
Other Locations
China
First Affiliated Hospital of Zhejiang University Schlool of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Tingbo Liang
liangtingbo@zju.edu.cn
+8619941463683
Backup
Yiwen Chen
yiwenchen0705@126.com
+8615088682641
Time Frame
Start Date: 2024-11-15
Estimated Completion Date: 2028-03
Participants
Target number of participants: 63
Treatments
Experimental: Phase 1 (Drug Tolerance Evaluation)
Using a 3 + 3 trial design, bortezomib dose exploration was performed to determine the stage 2 bortezomib dose. The number of participants at this stage is 6-9.
Experimental: Phase 2 (Dose extension)
Phase 2: This phase will adopt competitive enrollment, and the Bayesian prediction probability method will be used to monitor the main efficacy index of the trial ORR in real time to determine the early termination or continue the trial. A maximum number of 57 patients were enrolled in this stage.
Related Therapeutic Areas
Sponsors
Leads: Zhejiang University

This content was sourced from clinicaltrials.gov