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Clinical Trial NCT06149689 (PTCA199-7) for Pancreatic Adenocarcinoma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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mFOLFIRINOX Plus Radiotherapy to Patients With CA19-9-normal Advanced Pancreatic Cancer (PTCA199-7) Phase 2 30

Recruiting
Clinical Trial NCT06149689 (PTCA199-7) is designed to study Treatment for Pancreatic Adenocarcinoma. It is a Phase 2 interventional study that is recruiting, having started on January 10, 2024, with plans to enroll 30 participants. Led by Fudan University, it is expected to complete by October 31, 2026. The latest data from ClinicalTrials.gov was last updated on August 7, 2025.
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.
Detailed Description
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 ...Show More
Official Title

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

Conditions
Pancreatic Adenocarcinoma
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • PTCA199-7
NCT ID Number
NCT06149689
Start Date (Actual)
2024-01-10
Last Update Posted
2025-08-07
Completion Date (Estimated)
2026-10-31
Enrollment (Estimated)
30
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalmFOLFIRINOX 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 \[2000 mg per square meter\] every 2 weeks). Four-week chemotherapy is considered as a cycle. Patients will be recommended to receive Intensity-Modulated Radiation Thera...Show More
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 \[2000 mg per square meter\] every 2 weeks). Four-week chemotherapy is considered as a cycle. Patients will be recommended to receive Intensity-Modulated Radiation Thera...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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
Outcome MeasureMeasure DescriptionTime 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)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.
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Study Responsible Party
Guopei Luo, Principal Investigator, Professor, Fudan University
Study Central Contact
Contact: Ying Yang, MD, 86 64175590, [email protected]
Contact: Guopei Luo, MD, [email protected]
1 Study Locations in 1 Countries
Shanghai Cancer Center, Shanghai, China
Ying Yang, MD, Contact, 86 21 64175590, [email protected]
Guopei Luo, MD, Principal Investigator
Recruiting