A
Indication details
- Control Arm
- Gemcitabine
- Therapeutic Indication
- Resected pancreatic cancer
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Pancreatic cancer
- Trial Name
- JASPAC 01
- NCT Number
- UMIN CTR (UMIN000000655)
- Trial Phase
- Phase III
Approval details
- FDA Approval
- Not FDA approved
- EMA Approval
- Not EMA approved
- Comment
- Approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Score generated for Pan-Asian Adapted Guidelines (PAGA) for Gastrointestinal Cancers
Primary Outcome(s)
- Primary Outcome(s)
- OS, non-inferiority study
- Evaluated Outcome
- OS
- Form(s)
- Form 1
Outcome Data
- OS Control
- 25.5 months, 5 year OS 24.4%
- OS Gain
- 20.0 months, 5 year OS gain 19.7%
- OS HR
- 0.57 (0.44–0.72); non-inferiority p<0.0001; superiority p<0.0001
Adjustments
- QoL Comment
-
QoL secondary endpoint. EQ-5D utility index over time for patient health-related quality of life: interaction to treatment by time 0.0598
Score (after adjustments)
- Curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 494
- Scorecard version
- 1
- Issue date
- 18.04.2025
Legend
Information about symbols, abbrevations and color codes
Red = negative
Green = positive
Grey = neutral
?
Grey + ? = neutral with pending data
- DFS
- Disease-Free Survival
- DoR
- Duration of Response
- EFS
- Event-Free Survival
- HR
- Hazard Ratio
- NEB
- No evaluable benefit
- NI
- Non-inferiority Study
- ORR
- Overall Response Rate
- OS
- Overall Surival
- pCR
- Pathological Complete Response/Remission
- PFS
- Progression-Free Survival
- QoL
- Quality of Life
- RFS
- Relapse-Free Survival
- RR
- Response Rate
QoL adjustments
Other adjustments*
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
QoL adjustments
Red = negative / deterioration
Green = positive / improvement
Other adjustments*
Red = negative / deterioration
Green = positive / improvement
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include:
- Long-term plateau in the survival curve
- Long-term plateau in the PFS curve
- Early stopping or crossover
- Only improved PFS mature data shows no OS advantage and no improved Qol.