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De klinische studie NCT06149689 (PTCA199-7) voor Pancreas Adenocarcinoom is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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mFOLFIRINOX Plus Radiotherapy to Patients With CA19-9-normal Advanced Pancreatic Cancer (PTCA199-7) Fase 2 30

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De klinische studie NCT06149689 (PTCA199-7) onderzoekt behandeling bij Pancreas Adenocarcinoom. Deze Fase 2 interventioneel-studie heeft de status rekruterend. Het doel is om 30 deelnemers te includeren vanaf 10 januari 2024. De studie wordt geleid door Fudan-universiteit en de voltooiing is gepland op 31 oktober 2026. Laatste update op ClinicalTrials.gov: 7 augustus 2025.
Beknopte samenvatting
The purpose of this study is to evaluate the efficacy of mFOLFIRINOX plus radiotherapy to Patients with CA19-9-normal Advanced Pancreatic Cancer.
Uitgebreide beschrijving
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 ...Toon meer
Officiële titel

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

Aandoeningen
Pancreas Adenocarcinoom
Publicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:
Andere studie-ID's
  • PTCA199-7
NCT-ID
NCT06149689
Startdatum (Werkelijk)
2024-01-10
Laatste update geplaatst
2025-08-07
Verwachte einddatum
2026-10-31
Inschrijving (Geschat)
30
Studietype
Interventioneel
FASE
Fase 2
Status
Rekruterend
Primaire doel
Behandeling
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelmFOLFIRINOX 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...Toon meer
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...Toon meer
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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)
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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)
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
  • 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 logoFudan-universiteit829 actieve klinische studies om te verkennen
Verantwoordelijke instantie
Guopei Luo, Hoofdonderzoeker, Professor, Fudan University
Centraal Contactpersoon
Contact: Ying Yang, MD, 86 64175590, [email protected]
Contact: Guopei Luo, MD, [email protected]
1 Studielocaties in 1 landen
Shanghai Cancer Center, Shanghai, China
Ying Yang, MD, Contact, 86 21 64175590, [email protected]
Guopei Luo, MD, Hoofdonderzoeker
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