AG vs mFOLFIRINOX as Neoadjuvant Therapy for Borderline Reseactable and Locally Advanced Pancreatic Cancer

NCT04617821 | Unknown Phase 3

• 1 other identifier: CSPAC-28
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-center, randomized, controlled phase Ⅲ study.

Conditions

Borderline Resectable Pancreatic Cancer; Locally Advanced Pancreatic Adenocarcinoma

Keywords

neoadjuvant chemotherapy; albumin bound paclitaxel; mFOLFIRINOX

Outcome Measures

Primary Outcomes (1)

• overall survival

  To evaluate the overall survival of patients with borderline resectable and locally advanced pancreatic cancer after treated neoadjuvant chemotherapy

  from randomization to death, up to 36 months

Secondary Outcomes (5)

• recurrence free survival

  from randomization to recurrence, up to 36 months

• objective response rate

  up to 36 months

• resection rate

  up to 36 months

• R0 resection

  up to 36 months

• postoperative complications

  up to 36 months

Study Arms (2)

albumin bound paclitaxel plus gemcitabine

EXPERIMENTAL

Albumin-bound paclitaxel and gemcitabine were given intravenous infusion, repeated every 4 weeks for 1, 8, and 15 days, for a total of 4 to 6 cycles.

Drug: Nab paclitaxel plus gemcitabine

mFOFLIRINOX

ACTIVE COMPARATOR

Intravenous oxaliplatin for 2 hours, day 1;Intravenous infusion of calcium formyl tetrahydrofolate (LV) for 2 h, day 1;Irinotecan intravenous infusion is added 30 minutes later for 90 minutes, day 1;Intravenous infusion of 5-fluorouracil (5-FU) continued for 46 hours.Repeat every 2 weeks for a total of 4-6 cycles.

Drug: mFOLFIRINOX

Interventions

Nab paclitaxel plus gemcitabine DRUG

Albumin-bound paclitaxel and gemcitabine are given intravenous infusion, repeated every 4 weeks for 1, 8, and 15 days, for a total of 4 to 6 cycle.

Also known as: AG regimen

albumin bound paclitaxel plus gemcitabine

mFOLFIRINOX DRUG

Intravenous oxaliplatin for 2 hours, day 1;Intravenous infusion of calcium formyl tetrahydrofolate (LV) for 2 h, day 1;Irinotecan intravenous infusion is added 30 minutes later for 90 minutes, day 1;Intravenous infusion of 5-fluorouracil (5-FU) continued for 46 hours.Repeat every 2 weeks for a total of 4-6 cycles.

Also known as: modified FOLFIRINOX regimen

mFOFLIRINOX

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed content obtained prior to treatment
• Age ≥18 years and ≤ 80 years
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1
• Radiographically confirmed after borderline resectable or locally advanced pancreatic adenocarcinoma.
• No any other anti-tumor therapy prior to neoadjuvant chemotherapy, including intervention chemoembolization, ablation, radiotherapy, chemotherapy and molecular targeted therapy.
• No any other anti-tumor therapy prior to neoadjuvant chemotherapy, including intervention chemoembolization, ablation, radiotherapy, chemotherapy and molecular targeted therapy.
• No serious blood system, heart, lung function abnormalities and immune defects (refer to the respective standards)
• White blood cell (WBC) ≥ 3 × 109/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelets (PLT) ≥ 100 × 109/L; Hemoglobin (Hgb)≥ 9 g/dL
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) ≤ 2.5 × institutional upper limit of normal (ULN); Total bilirubin (TBIL) ≤ ULN; Creatinine (CRE) ≤ 1.5 × ULN
• Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 ×ULN
• Comply with research visit plans and other program requirements.

You may not qualify if:

• with other systemic malignancies
• Patients who were treated with any other anti-tumor therapy prior to neoadjuvant chemotherapy, including intervention chemoembolization, ablation, radiotherapy, chemotherapy and molecular targeted therapy.
• used any other study drug within 7 days prior to enrollment;
• Patients with central nervous system diseases, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled
• History of allergic reactions attributed to compounds of similar chemical or biological composition to study drug and alike.
• Patients who are using and expected to use warfarin in long term
• Patients may leave the observation for 14 days or more during the study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

Taxes; Gemcitabine

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Xian-Jun Yu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xian-Jun Yu, MD, PhD

CONTACT

+86 21 64175590; yuxianjun@fudanpci.org

Wen-Quan Wang, MD, PhD

CONTACT

+86 21 64175590; wangwenquan@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open-label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Fudan University Shanghai Cancer Center

Model Details: Three hundred patients with borderline resectable and locally advanced pancreatic cancer are randomized 1:1 to the AG and mFOLFIRINOX chemotherapy groups and to observe the total survival.

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 5, 2020
• Study Start: September 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 28, 2022

Record last verified: 2022-01

Locations

CN (1)