SNIPER-LTFU: Long-term follow-up study of patients administered with RR001 in the interventional Parent SNIPER study

Conditions

Locally advanced, non-resectable pancreatic adenocarcinoma, Ductal adenocarcinoma of pancreas

Brief summary

Incidence of long-term safety events reported during the Follow-Up (FU) period (93 months LTFU period)

Detailed description

Radiological assessment of disease progression performed per standard of care, Overall Survival (OS), Progression Free Survival (PFS), and Time to Progression (TTP), assessed over a 93 month Long Term follow-up period, Documentation of any subsequent antitumoral treatments and any participation in interventional clinical trials during the long-term follow-up period (93 months LTFU period), Collection of information on hospitalizations related to the underlying disease or to complications potentially linked to the SNIPER study during the long-term follow-up period, Monitor mechanism of action and efficacy using blood and tumoral samples and radiological data

Related papers

No related papers found yet.

Interventions

DRUGRR001

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of long-term safety events reported during the Follow-Up (FU) period (93 months LTFU period)	—

Secondary

Measure	Time frame
Radiological assessment of disease progression performed per standard of care, Overall Survival (OS), Progression Free Survival (PFS), and Time to Progression (TTP), assessed over a 93 month Long Term follow-up period, Documentation of any subsequent antitumoral treatments and any participation in interventional clinical trials during the long-term follow-up period (93 months LTFU period), Collection of information on hospitalizations related to the underlying disease or to complications potentially linked to the SNIPER study during the long-term follow-up period, Monitor mechanism of action and efficacy using blood and tumoral samples and radiological data	—

Measure

Time frame

Radiological assessment of disease progression performed per standard of care, Overall Survival (OS), Progression Free Survival (PFS), and Time to Progression (TTP), assessed over a 93 month Long Term follow-up period, Documentation of any subsequent antitumoral treatments and any participation in interventional clinical trials during the long-term follow-up period (93 months LTFU period), Collection of information on hospitalizations related to the underlying disease or to complications potentially linked to the SNIPER study during the long-term follow-up period, Monitor mechanism of action and efficacy using blood and tumoral samples and radiological data

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Outcome results

None listed