4
Indication details
- Control Arm
- Placebo
- Therapeutic Indication
- As monotherapy for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Hepatobiliary Cancers - Hepatocellular Carcinoma
- Tumour Stage
- Locally advanced
- Trial Name
- RESORCE
- NCT Number
- NCT01774344
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval April 2017
- EMA Approval
- EMA (CHMP) June 2017 EC decision August 2017
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 7.8 months
- OS Gain
- 2.8 months. 2-year survival gain ≥10% (only 5% experimental arm patients evaluable)
- OS HR
- 0.63 (0.50 - 0.79)
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 116
- Scorecard version
- 1
- Issue date
- 14.01.2019
- Last update
- 20.11.2024
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.