MFOLFIRINOX Plus Radiotherapy To Patients With CA19-9-normal Advanced Pancreatic Cancer

Study Overview

mFOLFIRINOX Plus Radiotherapy to Patients With CA19-9-normal Advanced Pancreatic Cancer

The purpose of this study is to evaluate the efficacy of mFOLFIRINOX plus radiotherapy to Patients with CA19-9-normal Advanced Pancreatic Cancer.

Pancreatic adenocarcinoma (PDAC) is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. In 2011, the PRODIGE trial has shown that oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) was associated with a survival advantage but had increased toxicity. Carbohydrate antigen 19-9 (CA19-9) is the most widely used biomarker in pancreatic cancer. Circulating CA19-9 levels are positively correlated with tumor burden and stage in pancreatic cancer with a diagnostic sensitivity of approximately 80%, suggesting that approximately 20% of patients have normal CA19-9 levels. It is well recognized that Lewis (-) individuals, constituting approximately 10% of the population, have low or no secretion of CA19-9 due to the lack of critical enzyme involved in CA19-9 biosynthesis. Thus, approximately 10% of patients with pancreatic cancer have normal CA19-9 levels regardless of tumor stage. Our previously retrospective study has shown that CA19-9-normal advanced pancreatic cancer may be more sensitive to chemotherapy combined with radiotherapy. The purpose of this study is to evaluate the efficacy of mFOLFIRINOX plus radiotherapy to patients with CA19-9-normal advanced pancreatic cancer. Progression-free survival (PFS), objective response rate (ORR), overall survival (OS) and disease control rate (DCR) are measured every four weeks.

Pancreatic Adenocarcinoma

COMBINATION_PRODUCT: mFOLFIRINOX plus radiotherapy

PTCA199-7

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 2023-11-21	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-04
First Submitted that Met QC Criteria 2023-11-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-08-07
First Posted (ACTUAL) 2023-11-29	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:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: mFOLFIRINOX plus radiotherapy Patients with advanced pancreatic adenocarcinoma will receive a modified FOLFIRINOX regimen (oxaliplatin [70 mg per square meter of body surface area], irinotecan [130 mg per square meter], leucovorin [200 mg per square meter], and fluorouracil [2000 mg p	COMBINATION_PRODUCT: mFOLFIRINOX plus radiotherapy Patients with advanced pancreatic adenocarcinoma will receive a modified FOLFIRINOX regimen (oxaliplatin [70 mg per square meter of body surface area], irinotecan [130 mg per square meter], leucovorin [200 mg per square meter], and fluorouracil [2000 mg p

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: mFOLFIRINOX plus radiotherapy

Patients with advanced pancreatic adenocarcinoma will receive a modified FOLFIRINOX regimen (oxaliplatin [70 mg per square meter of body surface area], irinotecan [130 mg per square meter], leucovorin [200 mg per square meter], and fluorouracil [2000 mg p

COMBINATION_PRODUCT: mFOLFIRINOX plus radiotherapy

Patients with advanced pancreatic adenocarcinoma will receive a modified FOLFIRINOX regimen (oxaliplatin [70 mg per square meter of body surface area], irinotecan [130 mg per square meter], leucovorin [200 mg per square meter], and fluorouracil [2000 mg p

Primary Outcome Measures	Measure Description	Time Frame
Overall survival，OS	OS of subjects from recruiting to the time of death from any cause	At the end of Cycle 1 (each cycle is 21 days)

Secondary Outcome Measures	Measure Description	Time Frame
progression-free survival, PFS	PFS of subjects from recruiting to the time of disease progression	At the end of Cycle 1 (each cycle is 21 days)
objective response rate (ORR)	CR + PR	At the end of Cycle 1 (each cycle is 21 days)
disease control rate (DCR)	CR + PR + SD	At the end of Cycle 1 (each cycle is 21 days)

Contacts and Locations

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

Study Contact

Name: Ying Yang, MD

Phone Number: 86 64175590

Email: yangying@fudanpci.org

Study Contact Backup

Name: Guopei Luo, MD

Phone Number:

Email: luoguopei@fudanpci.org

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:

Ability to understand and the willingness to sign a written informed consent document.
Age ≥ 18 years and ≤ 80 years.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Histologically or cytologically confirmed advanced pancreas adenocarcinoma.
Patients who have not received any form of anti-tumor therapy.
Baseline serum CA19-9 ≤ 37 U/mL, CEA≤ 5.2 ng/mL, and CA125 ≤ 35 U/mL.
Presence of at least of one measurable lesion in agreement to RECIST criteria.
The expected survival ≥ 3 months.
Adequate organ performance based on laboratory blood tests.
Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Pregnant or nursing women.
Patients who have received any form of anti-tumor therapy.
Baseline serum CA19-9 > 37 U/mL, CEA > 5.2 ng/mL, or CA125 > 35 U/mL.
The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.
Renal insufficiency or dialysis
Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
Patients who are allergic to oxaplatin or other chemotherapy drugs.
Patients who are unwilling or unable to comply with study procedures.

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Guopei Luo, MD, Fudan University

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

Luo G, Liu C, Guo M, Long J, Liu Z, Xiao Z, Jin K, Cheng H, Lu Y, Ni Q, Yu X. CA19-9-Low&Lewis (+) pancreatic cancer: A unique subtype. Cancer Lett. 2017 Jan 28;385:46-50. doi: 10.1016/j.canlet.2016.10.046. Epub 2016 Nov 10.
Luo G, Jin K, Guo M, Cheng H, Liu Z, Xiao Z, Lu Y, Long J, Liu L, Xu J, Liu C, Gao Y, Ni Q, Yu X. Patients with normal-range CA19-9 levels represent a distinct subgroup of pancreatic cancer patients. Oncol Lett. 2017 Feb;13(2):881-886. doi: 10.3892/ol.2016.5501. Epub 2016 Dec 14.
Luo G, Liu C, Guo M, Cheng H, Lu Y, Jin K, Liu L, Long J, Xu J, Lu R, Ni Q, Yu X. Potential Biomarkers in Lewis Negative Patients With Pancreatic Cancer. Ann Surg. 2017 Apr;265(4):800-805. doi: 10.1097/SLA.0000000000001741.

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