SHARP
SHARP was the 2008 trial that gave liver cancer its first life-extending drug.
Median OS 10.7 vs 7.9 months (HR 0.69); time to radiologic progression 5.5 vs 2.8 months. Response rate only 2%, establishing that disease stabilisation, not shrinkage, drives benefit with anti-angiogenics. Replicated in the Asia-Pacific trial (OS 6.5 vs 4.2 months).
Setting
Advanced HCC, Child-Pugh A, no prior systemic therapy: sorafenib vs placebo
Phase
Phase 3
Sponsor
Bayer
Registry
Headline result
OS 10.7 vs 7.9 months, HR 0.69.
Reported
2008
Enrolled
602
Replication
Confirmed by the parallel Asia-Pacific trial (Cheng 2009) and a decade of real-world use.
In plain words
What these results mean for people, not percentages
Overall survivalprimarysurvival endpoint
- Median 10.7 vs 7.9 months with Sorafenib compared with Placebo; about 2.8 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 31 percent lower chance of the event at any given time (hazard ratio 0.69, likely range 0.55 to 0.87).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Time to radiologic progressionother endpoint
- Median 5.5 vs 2.8 months with Sorafenib compared with Placebo; about 2.7 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 42 percent lower chance of the event at any given time (hazard ratio 0.58).
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
Be careful
- These results apply to the people the trial enrolled: Advanced HCC, Child-Pugh A, no prior systemic therapy: sorafenib vs placebo. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
602 participants enrolled.
Overall survivalprimary
HR 0.69 (0.55–0.87) · p <0.001
Sorafenib
10.7 mo
Placebo
7.9 mo
Time to radiologic progression
HR 0.58
Sorafenib
5.5 mo
Placebo
2.8 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Sorafenib | 299 | 10.7 months | 0.69 (0.55–0.87) | <0.001 | — |
| Placebo | 303 | 7.9 months | ||||
| Time to radiologic progression | Sorafenib | — | 5.5 months | 0.58 | — | — |
| Placebo | — | 2.8 months |
Replication
Confirmed by the parallel Asia-Pacific trial (Cheng 2009) and a decade of real-world use.