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

NCT ID: NCT03750669

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-20
• Study Completion Date: 2025-03-01

Brief Summary

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.

Detailed Description

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.

Conditions

Pancreatic Adenocarcinoma Resectable; Neoadjuvant Chemotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant Chemotherapy

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

Group Type: EXPERIMENTAL

AG regimen

Intervention Type: DRUG

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

mFolfirinox

Intervention Type: DRUG

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

control

Patients receive surgical treatment without any neoadjuvant treatments.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

AG regimen

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

Intervention Type: DRUG

mFolfirinox

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

Intervention Type: DRUG

Other Intervention Names

Nab-paclitaxel and Gemcitabine; Folic acid, 5- fluorouracil, irinotecan and oxaliplatin

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

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

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Liang Tingbo

Director of HBP Surgery, The Second Affiliated Hospital Zhejiang University School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tingbo Liang, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of HBP Surgery, SAHZJU

Locations

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

CISPD-1

Identifier Type: -

Identifier Source: org_study_id