Clinical trial · Interventional
Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer
A Phase II Study of Octreotide Acetate for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma
NCT00257426CI-TRIAL-00006253completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Octreotide may stop or slow the growth of tumor cells and may be an effective treatment for liver cancer. PURPOSE: This phase II trial is studying how well octreotide works in treating patients with locally advanced or metastatic liver cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| octreotide acetate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Median survival
- timeFrame
- 6 months
Secondary outcomes (1)
- measure
- number of subjects with toxicities
- timeFrame
- 6 months
- description
- Toxicities will be graded using the NCI's Common Toxicity Criteria, Version 2.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Newly diagnosed or recurrent hepatocellular carcinoma (HCC) as defined by tissue biopsy OR alpha fetoprotein (AFP) \> 1,000 ng/mL with compatible mass on CT scan or MRI * Recurrence of previously resected HCC will not require tissue confirmation if there is clear radiographic recurrence, in the judgment of the investigator * Locally advanced OR metastatic disease * Unmeasurable disease allowed if initial diagnosis was made according to the above criteria and/or recurrence has been confirmed by tissue biopsy or radiological imaging * CLIP score ≥ 3 * Not a candidate for surgical resection or liver transplant * Not a candidate for loco-regional therapy (e.g., ablation, embolization, hepatic arterial infusion therapy), but could have received such therapy in the past * No fibrolamellar HCC * No clinically apparent central nervous system metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: * Life expectancy ≥ 8 weeks * Karnofsky performance status 60-100% * Hemoglobin ≥ 8.5 g/dL * Platelet count ≥ 50,000/mm³ * Total bilirubin ≤ 5.0 mg/dL * AST or ALT ≤ 5 times upper limit of normal (ULN) * Creatinine ≤ 2 times ULN * PT ≤ 28 * INR ≤ 2.5 * No active variceal bleeding within the past 3 months * No encephalopathy grade 3-4 * No ongoing ethanol or intravenous drug abuse * Not pregnant or breast feeding PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Any number of prior therapies (e.g., chemotherapy, resection, embolization, or radiofrequency/ethanol ablation therapy) allowed * No concurrent chemotherapy, radiotherapy, or immunotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.