Phase I Open-Label Randomized Multicenter Study of XNW28012 Monotherapy in Metastatic Pancreatic Cancer
NCT07707674
Digestive System Diseases, Digestive System Neoplasms
Detroit, Michigan, United States
View Trial DetailsNCT Number: NCT06688240
The aim of this phase 4 study is to evaluate the safety profile of ONIVYDE in China mainland.
Primary objective
To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects:
1. Quantify the rate of grade ≥3 neutropenia (primary objective) 2. Serious adverse events and serious adverse drug reactions 3. Adverse events and adverse drug reactions Secondary objective To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland.
(1) Overall survival (2) Overall response (3) Progression free survival (4) Quality of life assessment
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From enrolment until 30 days after last ONIVYDE administration
(1) Quantify the rate of grade ≥3 neutropenia (primary objective)
Time frame: From enrolment until 30 days after last ONIVYDE administration
(2) Serious adverse events and serious adverse drug reactions
Time frame: From enrolment until 30 days after last ONIVYDE administration
(3) Adverse events and adverse drug reactions
Time frame: From FPI to 12 months after LPI
(1) Overall survival
Time frame: From FPI to 12 months after LPI
(2) Overall response
Time frame: From FPI to 12 months after LPI
(3) Progression free survival
Time frame: From FPI to 12 months after LPI
(4) Quality of life assessment(e.g.Karnofsky Performance Status (KPS))
Contact information is provided by the study sponsor or research team.
Servier (Tianjin) Pharmaceutical Co. LTD.
Industry
Acronym: SEOPAC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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