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

NCT06572813 | Recruiting Phase 1

• 1 other identifier: CISPD-7
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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

Conditions

Pancreas Cancer

Keywords

metastatic pancreatic cancer; bortezomib; PD-1 antibody; chemotherapy

Outcome Measures

Primary Outcomes (2)

• Phase 1: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Number of participants with treatment-related adverse events as assessed by CTCAE v5.0，including Complete Blood Count, liver function, renal function lab test and other blood test will be evaluated by using CTCAE 5.0 during study.

  Up to 2 years.

• Phase 2: Objective reponse rate (ORR)

  The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during phase 2

  Up to 2 years

Secondary Outcomes (4)

• Disease control rate (DCR)

  Up to 2 years

• Duration of remission （DoR）

  Up to 2 years

• Progression-free survival （PFS）

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

Study Arms (2)

Phase 1 (Drug Tolerance Evaluation)

EXPERIMENTAL

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.

Drug: Bortezomib Injection; Drug: Sintilimab; Drug: mFOLFIRINOX

Phase 2 (Dose extension)

EXPERIMENTAL

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.

Drug: Bortezomib Injection; Drug: Sintilimab; Drug: mFOLFIRINOX

Interventions

Bortezomib Injection DRUG

Bortezomib Injection, a kind of chemotherapy drug

Phase 1 (Drug Tolerance Evaluation); Phase 2 (Dose extension)

Sintilimab DRUG

PD-1 antibody

Phase 1 (Drug Tolerance Evaluation); Phase 2 (Dose extension)

mFOLFIRINOX DRUG

Combination of oxaliplatin, fluorouracil, irinotecan, leucovorin calcium

Phase 1 (Drug Tolerance Evaluation); Phase 2 (Dose extension)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

First Affiliated Hospital of Zhejiang University Schlool of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Bortezomib; sintilimab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tingbo Liang

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tingbo Liang

CONTACT

+8619941463683; liangtingbo@zju.edu.cn

Yiwen Chen

CONTACT

+8615088682641; yiwenchen0705@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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 subjects with advanced metastatic pancreatic cancer; Secondary Objective: 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.

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 27, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 10, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)