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

NCT03750669 | Completed Phase 3

• 1 other identifier: CISPD-1
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Adenocarcinoma Resectable; Neoadjuvant Chemotherapy

Keywords

Pancreatic Cancer; Pancreatic Adenocarcinoma; Gemcitabine; Nab-paclitaxel; Modified Folfirinox; Sequential treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall survival

  From randomization to death due to any cause. Up to approximately 60 months.

• Objective response rate

  From randomization to the end of neoadjuvant therapy. Up to approximately 60 months.

• Carbohydrate antigen 19-9

  Up to approximately 60 months

• Serious adverse events incidence

  Up to approximately 60 months

Study Arms (2)

Neoadjuvant Chemotherapy

EXPERIMENTAL

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

Drug: AG regimen; Drug: mFolfirinox

control

NO INTERVENTION

Patients receive surgical treatment without any neoadjuvant treatments.

Interventions

AG regimen DRUG

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

Also known as: Nab-paclitaxel and Gemcitabine

Neoadjuvant Chemotherapy

mFolfirinox DRUG

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

Also known as: Folic acid, 5- fluorouracil, irinotecan and oxaliplatin

Neoadjuvant Chemotherapy

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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Gemcitabine; Folic Acid; Fluorouracil; Irinotecan; Oxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Uracil; Pyrimidinones; Camptothecin; Alkaloids; Coordination Complexes; Organic Chemicals

Study Officials

• Tingbo Liang, MD PhD

  Department of HBP Surgery, SAHZJU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of HBP Surgery, The Second Affiliated Hospital Zhejiang University School of Medicine

Study Record Dates

• First Submitted: November 17, 2018
• First Posted: November 23, 2018
• Study Start: October 20, 2018
• Primary Completion: November 1, 2024
• Study Completion: March 1, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-03

Locations

CN (1)