Sequential Use Of AG And MFOLFIRINOX As Neoadjuvant Chemotherapy For Resectable Pancreatic Cancer

Study Overview

Sequential Use of AG and mFOLFIRINOX as Neoadjuvant Chemotherapy for Resectable Pancreatic Cancer

The prognosis of pancreatic cancer is extremely poor. Current guidelines recommend Nab-paclitaxel, Gemcitabine and modified Folfirinox as the first-line chemotherapeutic regimen. Studies have shown that sequential chemotherapeutic regimen can effectively delay the drug resistance and improve the effect of chemotherapy. Here investigators intend to assess the effect of sequential treatment with Nab-paclitaxel plus Gemcitabine and modified Folfirinox as neoadjuvant chemotherapy for resectable pancreatic adenocarcinoma.

Investigators chose resectable pancreatic adenocarcinoma patients. The planned treatment was given to the participants after randomization. Tumor size, event-free survival, overall survival, drugs related side effects and other endpoints events were recorded and analyzed, to assess the sequential treatment with Nab-paclitaxel plus Gemcitabine and modified Folfirinox could or couldn't benefit the prognosis of resectable pancreatic adenocarcinoma.

Pancreatic Adenocarcinoma Resectable
Neoadjuvant Chemotherapy

DRUG: AG regimen
DRUG: mFolfirinox

CISPD-1

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 2018-11-17	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-07
First Submitted that Met QC Criteria 2018-11-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-13
First Posted (ACTUAL) 2018-11-23	Results First Posted N/A	Last Verified 2025-03

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: Neoadjuvant Chemotherapy Patients receive the sequential neoadjuvant chemotherapy of AG regimen (nab-paclitaxel plus gemcitabine) and mFOLFIRINOX before resection.	DRUG: AG regimen Combination of Nab-paclitaxel 125 mg/m^2 and Gemcitabine 1000 mg/m^2 DRUG: mFolfirinox Folic acid 400mg/m^2, 5- fluorouracil 2400mg/m^2 for 46h, irinotecan 135mg/m^2 and oxaliplatin 68mg/m^2
NO_INTERVENTION: control Patients receive surgical treatment without any neoadjuvant treatments.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Neoadjuvant Chemotherapy

Patients receive the sequential neoadjuvant chemotherapy of AG regimen (nab-paclitaxel plus gemcitabine) and mFOLFIRINOX before resection.

DRUG: AG regimen

Combination of Nab-paclitaxel 125 mg/m^2 and Gemcitabine 1000 mg/m^2

DRUG: mFolfirinox

Folic acid 400mg/m^2, 5- fluorouracil 2400mg/m^2 for 46h, irinotecan 135mg/m^2 and oxaliplatin 68mg/m^2

NO_INTERVENTION: control

Patients receive surgical treatment without any neoadjuvant treatments.

Primary Outcome Measures	Measure Description	Time Frame
event-free survival (EFS)	Event-Free Survival assessed by the investigator according to RECIST 1.1 by investigator, defined as the time from randomization to any of the following events: progression of disease that precludes resection, local or distant recurrence, or death due to any cause, whichever occurs first.	From randomization to any of the following events: progression of disease that precludes resection, local or distant recurrence, or death due to any cause, whichever occurs first. Up to approximately 60 months.

Secondary Outcome Measures	Measure Description	Time Frame
Overall survival	Overall survival, the time from randomization to death due to any cause	From randomization to death due to any cause. Up to approximately 60 months.
Objective response rate	The proportion of patients with tumor size reduction of a predefined amount and for a minimum time period	From randomization to the end of neoadjuvant therapy. Up to approximately 60 months.
Carbohydrate antigen 19-9	Serum Carbohydrate antigen 19-9 level	Up to approximately 60 months
Serious adverse events incidence	The proportion of patients with grade 3/4 adverse events	Up to approximately 60 months

Contacts and Locations

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

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:

Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC).
No evidence of distant metastasis (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.
Initial assessment for definitive resectable tumors (resectability judgment is based on CT enhanced scan or magnetic resonance imaging, NCCN2018 first edition standard).
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.
If biliary obstruction is observed, biliary decompression should be performed when the patient is randomly assigned to receive neoadjuvant chemotherapy.
Leukocyte count (> 3.5 x 10^6 /mL), neutrophil count (> 1.5 x 10^6 /mL), platelet count (> 80 x 10^6 /mL), hemoglobin (> 9 g/dL).
Signed informed consent.

History of malignance treatment in the past, excluding basal and cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma
Tumor is a local recurrent lesion.
Imaging confirmed severe portal hypertension / cavernous transformation.
Ascites
Gastric outlet obstruction
Respiratory failure requires supplementation of oxygen.
Immune deficiency syndrome, such as active tuberculosis and HIV infection.
Hematological precancerous diseases, such as myelodysplastic syndromes.
Major cardiovascular diseases (including myocardial infarction, unstable angina, congestive heart failure, severe uncontrolled arrhythmia) during the past six months of enrollment.
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).
Allograft requires immunosuppressive therapy or other major immunosuppressive therapies.
Severe serious wounds, ulcers or fractures.
Confirmed coagulant disease.
Clinical evaluation is unacceptable.

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Tingbo Liang, MD PhD, Department of HBP Surgery, SAHZJU

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

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