Clinical trial · Interventional
Trial of Thalidomide, a- Interferon +/- Octreotide in Patients With Unresectable Hepatocellular Carcinoma
NCT00250796CI-TRIAL-00002985completedPhase 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)
Primary Aim Determine the response rate and time to progression of the combination of thalidomide, interferon, and octreotide in patients with unresectable hepatocellular carcinoma (cancer of the liver that can't be treated surgically). Secondary Aims 1. Determine the toxicity of this combination in this population. 2. Determine the survival of this patient cohort treated with the combination. 3. Determine the percent of patients with hepatocellular carcinoma who have a positive octreotide scan.
Conditions
Conditions (2)
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 |
| Liver | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thalidomide, alpha interferon | Drug | — | UNRESOLVED |
| Thalidomide, interferon, Octreotide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1
- description
- Thalidomide+alpha interferon
- interventionNames
- Drug: Thalidomide, alpha interferon
- type
- EXPERIMENTAL
- label
- Arm 2
- description
- Thalidomide+interferon+Octreotide
- interventionNames
- Drug: Thalidomide, interferon, Octreotide
Primary outcomes (1)
- measure
- Determine the response rate and time to progression of the combination of thalidomide, interferon, and octreotide in patients with unresectable hepatocellular carcinoma.
- timeFrame
- Disease progression and toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically proven diagnosis of hepatocellular or radiographic evidence of a hepatic lesion consistent with hepatoma and an alpha feto protein \>500 ng/ ml 2. The tumor is unresectable 3. Performance status of \< 2.0 4. \> 18 years of age 5. Informed consent to be signed by patient 6. No previous treatment with thalidomide, alpha interferon, or octreotide 7. The patient may have received previous chemotherapy either systemically or via the intra hepatic artery. 8. The patient may have had previous surgery or regional therapy such as intra tumoral injection of alcohol, cryosurgery, or radiofrequency ablation. 9. The patient must have measurable disease. 10. If female, the patient must have a negative pregnancy test and agree not to fall pregnant during this therapy. 11. Bilirubin \<3 X ULN, AST/ALT\<3 X ULN, creat\<2, ANC\>1.5, Platelet\>75K 12. Patients may not have symptomatic cholelithiasis. Exclusion Criteria:
References
Publications (0)
Data not yet available
No reference posted for this study.