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mFOLFIRINOX Plus Radiotherapy to Patients With CA19-9-normal Advanced Pancreatic Cancer (PTCA199-7) Phase II 30

En recrutement
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L'essai clinique NCT06149689 (PTCA199-7) est conçu pour étudier le traitement de Adénocarcinome pancréatique. Il s'agit d'une étude interventionnel en Phase II. Son statut actuel est : en recrutement. L'étude a débuté le 10 janvier 2024 et vise à recruter 30 participants. Dirigée par l'Université Fudan, l'étude devrait être terminée d'ici le 31 octobre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 7 août 2025.
Résumé succinct
The purpose of this study is to evaluate the efficacy of mFOLFIRINOX plus radiotherapy to Patients with CA19-9-normal Advanced Pancreatic Cancer.
Description détaillée
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 ...Afficher plus
Titre officiel

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

Pathologies
Adénocarcinome pancréatique
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'étude
  • PTCA199-7
Numéro NCT
NCT06149689
Date de début (réel)
2024-01-10
Dernière mise à jour publiée
2025-08-07
Date de fin (estimée)
2026-10-31
Inscription (estimée)
30
Type d'étude
Interventionnel
PHASE
Phase II
Statut
En recrutement
Objectif principal
Traitement
Méthode d'allocation
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalmFOLFIRINOX 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...Afficher plus
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...Afficher plus
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
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)
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
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)
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  • 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.
Fudan University logoUniversité Fudan829 essais cliniques actifs à explorer
Partie responsable de l'étude
Guopei Luo, Investigateur principal, Professor, Fudan University
Contact central de l'étude
Contact: Ying Yang, MD, 86 64175590, [email protected]
Contact: Guopei Luo, MD, [email protected]
1 Centres de l'étude dans 1 pays
Shanghai Cancer Center, Shanghai, China
Ying Yang, MD, Contact, 86 21 64175590, [email protected]
Guopei Luo, MD, Investigateur principal
En recrutement