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

Locally Advanced Pancreatic Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04617821
• Other study ID #: CSPAC-28
• Status: Recruiting
• Phase: Phase 3
• Start date: September 1, 2021
• Est. completion date: September 2024

Study information

• Verified date: January 2022
• Source: Fudan University
• Contact: Xian-Jun Yu, MD, PhD
• Phone: +86 21 64175590
• Email: yuxianjun[@]fudanpci.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Borderline Resectable Pancreatic Cancer
• Locally Advanced Pancreatic Adenocarcinoma
• Pancreatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	resection rate	The proportion of patients who become operable from inoperable after neoadjuvant chemotherapy.	up to 36 months
Secondary	R0 resection	The proportion of R0 resection among patients who undergo operations.	up to 36 months
Secondary	postoperative complications	The incidence of postoperative complications	up to 36 months