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NCT04083235Active studySynthetic mock data

NAPOLI-3 (simulated)

Ipsen — Phase 3 pancreatic adenocarcinoma trial. RECIST 1.1 endpoint review across 400 enrolled cases.

Review endpoints

Endpoint review progress

99%

1529 of 1541 endpoints reached

Adjudication κ 0.81 · data freeze Mar 18

Cases enrolled

400

400 active

Confirmed responders

154

39% ORR

Open imaging review

0

Pending annotation

Endpoint events

1,529

RECIST CR/PR/PD

Disease burden trajectory

Median tumor diameter, RECIST sum, by arm

Arm AArm B
808896104112081624324048566472808896104112% of baseline
Wk 0 → 32 since enrollmentDrill into cohort

Protocol quality

Endpoint adjudication agreement, by arm

Arm AArm B
65758595105048121620242832% agreement
Wk 0 → 32 since enrollmentDrill into cohort

Structural endpoint summary

Locked

Adjudication consensus81%

Risk-group distribution (A–J)

14,999 patients · PANDA classification across the surveillance population

Very low (A–C): 14,111Low (D–F): 338Moderate (G–H): 150High (I–J): 400
A
Healthy
B
Comorbidities
C
Abdominal pain ≥50
D
Risk factors
E
Imaging ordered
F
Cyst confirmed
G
EUS surveilled
H
Tumor confirmed
I
On treatment
J
Stage IV / progressing

Treatment-pathway comparison

NAPOLI-3 (simulated) (NCT04083235) — best-response rates and time-to-progression by arm and stage

Leading arm: Gemcitabine + nab-paclitaxel · 47% ORR

NALIRIFOX

201 patients

ORR

46%

92 responders

Median TTP

287 d

baseline → first PD

Progressed

35%

of 201

Best response by stage subgroup

Stage I
39% · 36
Stage II
44% · 34
Stage III
43% · 58
Stage IV
52% · 73

Gemcitabine + nab-paclitaxel

199 patients

ORR

47%

93 responders

Median TTP

260 d

baseline → first PD

Progressed

40%

of 199

Best response by stage subgroup

Stage I
48% · 27
Stage II
49% · 45
Stage III
49% · 51
Stage IV
43% · 76

High-cost drug utilization

Exposure, duration on therapy, discontinuation pattern, and best response across the active oncology regimens

AgentClassPatientsMedian durationDiscontinuedCR / PR rate
GemcitabineChemotherapy224386 d100%45%
OxaliplatinChemotherapy186394 d69%46%
LeucovorinChemotherapy186394 d69%46%
Nab-paclitaxelChemotherapy183382 d100%44%
IrinotecanChemotherapy176394 d100%48%
Fluorouracil (5-FU)Chemotherapy176394 d100%48%
CisplatinChemotherapy180 d100%17%

Median duration is end-date minus start-date across discontinued regimens. Response rate is per unique patient (best of CR/PR across the patient's RECIST history).

Evidence streams fed by the current window

Modalities and feeds linked to the active protocol cohort

Manage feeds →

CT scan

Indexed

2,046

Across 400 enrolled cases

MRI

Indexed

339

DICOM normalized

EUS scan

Needs review

400

400 with FNA tissue sample

Pathology

Indexed

400

Slide registry linked

CA 19-9 / biomarker

Indexed

3,985

Serial CA 19-9 draws

Concomitant meds

Indexed

2,083

EHR + reconciled

Patient overlap between case sets

Cohort intersection across arms, screening pool, and shared cases

Open cohort builder →
48

Arm A only

142

Arm B only

124

In both arms

48

Screen-only

31

Overlap composition

345 unique cases tracked·48 shared between arms·14 cases pending re-randomization

Imaging adjudication queue

Endpoint reviews assigned across the current window

Open queue →
P3-1432-018CTWk 16Dr. Wagner2dIn reviewP3-1432-022MRIWk 12Dr. Wagner4dSecond readP3-1432-031CTWk 20Dr. Lin1dIn reviewP3-1432-039EUSWk 12Dr. Patel3dIn reviewP3-1432-044CTWk 24Dr. Lin5dSecond readP3-1432-051PathWk 16Dr. Yuen1dIn review

Available research packages

  • RECIST 1.1 export bundle

    All adjudicated lesion measurements

    3963 measurements

  • Endpoint event log

    RECIST response events with arm allocation

    1529 events

  • Imaging cohort

    Linked DICOM + reads

    2785 series

  • Biomarker panel

    Serial CA 19-9 + supporting labs

    3985 draws

  • Concomitant med log

    Reconciled medication histories

    3148 entries