Clinical trial · Interventional
Phase III Study of PI-88 in Post-resection Hepatocellular Carcinoma
A Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, International, Multicentre Phase III Trial of PI-88 in the Adjuvant Treatment of Post-resection Hepatocellular Carcinoma
NCT00568308CI-TRIAL-00005015PATHWAYterminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Commercial decision to discontinue the study
Summary
Brief summary (as posted)
The purpose of this study is to determine if PI-88 is effective and safe in patients who have had surgery to remove primary liver cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatoma | Hepatocellular Carcinoma | ALIAS | 0.90 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Primary Liver Cancer | Liver Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PI-88 | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- 1
- interventionNames
- Drug: placebo
- type
- EXPERIMENTAL
- label
- 2
- interventionNames
- Drug: PI-88
Primary outcomes (1)
- measure
- Disease-free Survival
- timeFrame
- End of Study
Secondary outcomes (5)
- measure
- Overall Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Histologically-proven primary hepatocellular carcinoma with curative resection performed in the 4 - 6 weeks prior to randomisation. * ECOG performance status 0 to 2 * Child Pugh classification A or B Key Exclusion Criteria: * Any evidence of tumour metastasis or co-existing malignant disease * Any prior recurrence of HCC or any liver resection prior to the most recent procedure * History of prior HCC therapy
References
Publications (0)
Data not yet available
No reference posted for this study.