Bortezomib Combined with PD-1 MAb and MFOLFIRINOX for Metastatic Pancreatic Cancer

NCT ID: NCT06572813

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2028-03-31

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

Detailed Description

Phase 1 (Evaluation of Drug Tolerance) Primary objective: To evaluate the tolerability of bortezomib, PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer, and to determine the dose of bortezomib in the combination regimen; Secondary objectives: To evaluate the immunogenicity characteristics and safety of the combination regimen of bortezomib, PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer; Phase 2 (Dose Expansion) Primary objective: To evaluate the tolerability and efficacy of the combination regimen of bortezomib, PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer; Secondary Objective: ORR; PFS; OS; and to evaluate the immunogenicity and safety of bortezomib, PD-1 mAb and mFOLFIRINOX in subjects with advanced metastatic pancreatic cancer; and to explore biomarkers related to combination therapy.

Conditions

Pancreas Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Bortezomib Injection

Intervention Type: DRUG

Bortezomib Injection, a kind of chemotherapy drug

Sintilimab

Intervention Type: DRUG

PD-1 antibody

mFOLFIRINOX

Intervention Type: DRUG

Combination of oxaliplatin, fluorouracil, irinotecan, leucovorin calcium

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.

Group Type: EXPERIMENTAL

Bortezomib Injection

Intervention Type: DRUG

Bortezomib Injection, a kind of chemotherapy drug

Sintilimab

Intervention Type: DRUG

PD-1 antibody

mFOLFIRINOX

Intervention Type: DRUG

Combination of oxaliplatin, fluorouracil, irinotecan, leucovorin calcium

Interventions

Bortezomib Injection

Bortezomib Injection, a kind of chemotherapy drug

Intervention Type: DRUG

Sintilimab

PD-1 antibody

Intervention Type: DRUG

mFOLFIRINOX

Combination of oxaliplatin, fluorouracil, irinotecan, leucovorin calcium

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

TingBo Liang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tingbo Liang

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

First Affiliated Hospital of Zhejiang University Schlool of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Tingbo Liang

Role: CONTACT

liangtingbo@zju.edu.cn

+8619941463683

Yiwen Chen

Role: CONTACT

yiwenchen0705@126.com

+8615088682641

Facility Contacts

Yiwen Chen, MD

Role: primary

cherry0705@zju.edu.cn

86+15088682641

Other Identifiers

CISPD-7

Identifier Type: -

Identifier Source: org_study_id