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

NCT06249321 | Recruiting Phase 2

• 1 other identifier: PTCA199-10
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Cancer; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• progression-free survival, PFS

  PFS of subjects from recruiting to the time of disease progression

  At the end of Cycle 1 (each cycle is 28 days)

Secondary Outcomes (3)

• Overall survival，OS

  At the end of Cycle 1 (each cycle is 28 days)

• objective response rate (ORR)

  At the end of Cycle 1 (each cycle is 28 days)

• disease control rate (DCR)

  At the end of Cycle 1 (each cycle is 28 days)

Study Arms (1)

mFOLFIRINOX plus radiotherapy

EXPERIMENTAL

Patients with advanced pancreatic adenocarcinoma will receive the 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 \[2000 mg per square meter\] every 2 weeks). Four-week chemotherapy is considered as a cycle. Patients will be recommended to receive Intensity-Modulated Radiation Therapy (IMRT) after about 2\~6 cycles of chemotherapy.

Drug: mFOLFIRINOX plus IMRT

Interventions

mFOLFIRINOX plus IMRT DRUG

Chemotherapy will be administered according to the newest edition of National Comprehensive Cancer Network (NCCN) guideline and a modified FOLFIRINOX regimen will be the first choice. Patients with advanced pancreatic adenocarcinoma will receive the 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 \[2000 mg per square meter\] every 2 weeks). Four-week chemotherapy is considered as a cycle. Patients will be recommended to receive Intensity-Modulated Radiation Therapy (IMRT) after about 2\~6 cycles of chemotherapy. The following treatment after radiotherapy will be applied according to the newest edition of NCCN guideline.

mFOLFIRINOX plus radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 are refractory to at least one line of chemotherapy and who have not received radiotherapy.
• Locally advanced or distant metastatic pancreatic cancer.
• 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.

You may not qualify if:

• Pregnant or nursing women.
• Primary pancreatic cancer.
• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 27840089 BACKGROUND

• 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.

  PMID: 28267695 BACKGROUND

• 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.

  PMID: 28356973 BACKGROUND

• Zhu X, Xiao Z, Liu H, Zhang P, Deng S, Ding L, Feng J, Luo J, Ni Q, Luo G, Yu X. Pancreatic Cancer: An Exocrine Tumor With Endocrine Characteristics. Ann Surg. 2024 Dec 1;280(6):e17-e25. doi: 10.1097/SLA.0000000000006168. Epub 2023 Dec 5.

  PMID: 38050737 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Guopei Luo, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Yang, MD

CONTACT

86 64175590; yangying@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: April 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 7, 2025

Record last verified: 2025-03

Locations

CN (1)