Clinical trial · Interventional
Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Primary Hepatocellular Carcinoma (HCC)
PhaseⅡ, Open Label, Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced or Primary Hepatocellular Carcinoma
NCT01308645CI-TRIAL-00004998HCCunknownPhase 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)
The purpose of this study is to determine efficacy of SB injection in Hepatocellular Carcinoma (HCC).
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SB injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluating Tumor Response Rate
- timeFrame
- 4 Months
Secondary outcomes (3)
- measure
- Pain Scores on the Visual Analog Scale
- timeFrame
- 4 Months
- measure
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability scale
- timeFrame
- 4 Months
- measure
- Determine duration of response rate by measuring time to progression
- timeFrame
- 4 Months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age of 18 years or over 2. Patients with Hepatocellular carcinoma progression (HCC) and primary liver cancer as a diagnostic imaging test (eg, X-ray, CT, scan, ultrasound) can be measured in patients with a lesion 3. Directly to standard therapy (surgery, RF ablation, TACE) is not possible, patients with advanced liver cancer. However, the standard treatment of the subject or subjects entirely voluntary participation of subjects participating at the discretion of the doctor or researcher can be deemed included in the selected target. 4. Life expectancy ≥ 5 months 5. ECOG status 0, 1, 2 patients 6. Child-Pugh classification A, B patients 7. PLT 70,000, ANC 1,000 or more patients (OT / PT \<upper normal limit x 5.0, Bilirubin \<upper normal limit x 3.0) 8. Female volunteers admitted to the study must be using a reliable means of contraception and must have a negative blood or urine pregnancy test at least 7 days ago 9. Patients or their legal representatives who have signed the informed consent form Exclusion Criteria: 1. Last 4 weeks the patients who had participated in another clinical trial 2. Last 4 weeks the patients who received chemotherapy 3. Associated with hepatocellular carcinoma in patients with a history of malignant tumor 4. Hepatectomy or liver transplantation patients who received treatment. 5. Active systemic infection requiring medical treatment 6. Uncontrolled hypertension or diabetes mellitus. 7. Clinically Significant cardiac disease (myocardial infarction / angina / severe arrhythmia / congestive heart failure) 8. Autoimmune diseases (systemic lupus erythematosus: SLE / rheumatoid arthritis / myasthenia gravis) and the patients currently being treated 9. Presence or history of malignancy other than Hepatocellular carcinoma within 5 years 10. Patients who have history of allergy with this investigational drug. 11. Obvious cognitive or physical impairment that would prevent participation 12. Pregnancy, lactation period and don't using contraception earnest Patients
References
Publications (0)
Data not yet available
No reference posted for this study.