NCT06572813 Bortezomib Combined with PD-1 MAb and MFOLFIRINOX for Metastatic Pancreatic Cancer
| NCT ID | NCT06572813 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Condition | Pancreas Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 63 participants |
| Start Date | 2024-11-15 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 63 participants in total. It began in 2024-11-15 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * History of participation of other clinical trails within 4 weeks * History of autoimmune disease or other condition receiving glucocorticoid treatment * History of receiving chemotherapy within 2 weeks * History of radiotherapy and molecular target therapy within 2 weeks * History if active tuberculosis * History of malignance treatment in the past, excluding basal and cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma * Major cardiovascular diseases (including myocardial infarction, unstable angina, congestive heart failure, severe uncontrolled arrhythmia) during the past six months of enrollment. * Hematological precancerous diseases, such as myelodysplastic syndromes. * Evidence of clinical-related or previous interstitial lung disease, such as noninfectious pneumonia or pulmonary fibrosis, or baseline chest CT scan or chest X-ray findings * Previous or physical findings of central nervous system disease, except for adequately treated (e.g. primary brain tumors, uncontrolled seizures or strokes with standard medications) * Preexisting neuropathy \> 1 (NCI CTCAE). * Immune deficiency syndrome, such as active tuberculosis and HIV infection. * Allograft requires immunosuppressive therapy or other major immunosuppressive therapies. * Severe serious wounds, ulcers or fractures. * Clinical evaluation is unacceptable
Contact & Investigator
Tingbo Liang
PRINCIPAL INVESTIGATOR
First Affiliated Hospital of Zhejiang University
Frequently Asked Questions
Who can join the NCT06572813 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pancreas Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06572813 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06572813 currently recruiting?
Yes, NCT06572813 is actively recruiting participants. Contact the research team at liangtingbo@zju.edu.cn for enrollment information.
Where is the NCT06572813 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06572813 clinical trial?
NCT06572813 is sponsored by First Affiliated Hospital of Zhejiang University. The principal investigator is Tingbo Liang at First Affiliated Hospital of Zhejiang University. The trial plans to enroll 63 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.