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

Primary Purpose

Borderline Resectable Pancreatic Cancer, Locally Advanced Pancreatic Adenocarcinoma

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Nab paclitaxel plus gemcitabine

mFOLFIRINOX

About this trial

This is an interventional treatment trial for Borderline Resectable Pancreatic Cancer focused on measuring neoadjuvant chemotherapy, albumin bound paclitaxel, mFOLFIRINOX

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

albumin bound paclitaxel plus gemcitabine

mFOFLIRINOX

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

overall survival

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

Secondary Outcome Measures

recurrence free survival

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

objective response rate

To evaluate the objective response rate of patients with borderline resectable and locally advanced pancreatic cancer after treated neoadjuvant chemotherapy

resection rate

The proportion of patients who become operable from inoperable after neoadjuvant chemotherapy.

R0 resection

The proportion of R0 resection among patients who undergo operations.

postoperative complications

The incidence of postoperative complications

Full Information

NCT ID

NCT04617821

First Posted

November 2, 2020

Last Updated

January 27, 2022

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT04617821

Brief Title

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

Official Title

A Phase Ⅲ, Randomized Controlled Study to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine Versus mFOLFIRINOX in Treating Patients With Borderline Reseactable and Locally Advanced Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2021 (Actual)

Primary Completion Date

September 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Borderline Resectable Pancreatic Cancer, Locally Advanced Pancreatic Adenocarcinoma

Keywords

neoadjuvant chemotherapy, albumin bound paclitaxel, mFOLFIRINOX

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

None (Open Label)

Masking Description

open-label

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

albumin bound paclitaxel plus gemcitabine

Arm Type

Experimental

Arm Description

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.

Arm Title

mFOFLIRINOX

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Nab paclitaxel plus gemcitabine

Other Intervention Name(s)

AG regimen

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

mFOLFIRINOX

Other Intervention Name(s)

modified FOLFIRINOX regimen

Intervention Description

Primary Outcome Measure Information:

Title

overall survival

Description

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

Time Frame

from randomization to death, up to 36 months

Secondary Outcome Measure Information:

Title

recurrence free survival

Description

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

Time Frame

from randomization to recurrence, up to 36 months

Title

objective response rate

Description

To evaluate the objective response rate of patients with borderline resectable and locally advanced pancreatic cancer after treated neoadjuvant chemotherapy

Time Frame

up to 36 months

Title

resection rate

Description

The proportion of patients who become operable from inoperable after neoadjuvant chemotherapy.

Time Frame

up to 36 months

Title

R0 resection

Description

The proportion of R0 resection among patients who undergo operations.

Time Frame

up to 36 months

Title

postoperative complications

Description

The incidence of postoperative complications

Time Frame

up to 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xian-Jun Yu, MD, PhD

Phone

+86 21 64175590

yuxianjun@fudanpci.org

First Name & Middle Initial & Last Name or Official Title & Degree

Wen-Quan Wang, MD, PhD

Phone

+86 21 64175590

wangwenquan@fudanpci.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xian-Jun Yu, MD, PhD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

XianJun Yu, M.D., Ph.D.

Phone

+86-21-6417-5590

yuxianjun@fudanpci.org

First Name & Middle Initial & Last Name & Degree

Xianjun Yu, M.D., Ph.D.

12. IPD Sharing Statement

Learn more about this trial

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

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