AG Vs MFOLFIRINOX As Neoadjuvant Therapy For Borderline Reseactable And Locally Advanced Pancreatic Cancer

Study Overview

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

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

Three hundred patients with borderline resectable and locally advanced pancreatic cancer will be randomized 1:1 (150 :150) to the AG and mFOLFIRINOX chemotherapy groups and to observe the overall survival. The AG regimen: 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 cycles. MFOLFIRINOX: 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. After neoadjuvant chemotherapy, the surgery will be evaluated according to the patient's tumor and systemic condition. The first cycle of adjuvant chemotherapy begins 4-8 weeks after radical resection, and the choice of adjuvant chemotherapy regimen depends on the response to neoadjuvant chemotherapy.If neoadjuvant chemotherapy is effective, adjuvant chemotherapy maintains the original regimen.Adjuvant chemotherapy has 4 cycles of treatment. Relevant examinations were performed before and after each cycle of medication to assess safety events, imaging review was performed every 2 cycles during the treatment period and every 3 months during the follow-up period.

Borderline Resectable Pancreatic Cancer
Locally Advanced Pancreatic Adenocarcinoma

DRUG: Nab paclitaxel plus gemcitabine
DRUG: mFOLFIRINOX

CSPAC-28

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-11-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-01-27
First Submitted that Met QC Criteria 2020-11-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-01-28
First Posted (ACTUAL) 2020-11-05	Results First Posted N/A	Last Verified 2022-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: albumin bound paclitaxel plus gemcitabine 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 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.
ACTIVE_COMPARATOR: mFOFLIRINOX 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	DRUG: mFOLFIRINOX 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: albumin bound paclitaxel plus gemcitabine

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

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.

ACTIVE_COMPARATOR: mFOFLIRINOX

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

DRUG: mFOLFIRINOX

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

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
recurrence free survival	To evaluate the recurrence free survival of patients with borderline resectable and locally advanced pancreatic cancer after treated neoadjuvant chemotherapy	from randomization to recurrence, up to 36 months
objective response rate	To evaluate the objective response rate of patients with borderline resectable and locally advanced pancreatic cancer after treated neoadjuvant chemotherapy	up to 36 months
resection rate	The proportion of patients who become operable from inoperable after neoadjuvant chemotherapy.	up to 36 months
R0 resection	The proportion of R0 resection among patients who undergo operations.	up to 36 months
postoperative complications	The incidence of postoperative complications	up to 36 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Xian-Jun Yu, MD, PhD

Phone Number: +86 21 64175590

Email: yuxianjun@fudanpci.org

Study Contact Backup

Name: Wen-Quan Wang, MD, PhD

Phone Number: +86 21 64175590

Email: wangwenquan@fudanpci.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Xian-Jun Yu, MD, PhD, Fudan University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record