Clinical trial · Observational
Phase ⅡStudy of Tyroserleutide for Injection in Hepatocellular Carcinoma(HCC) Patients
A Randomized, Double Blind, Placebo Controled, Multicenter Phase ⅡStudy to Evaluate the Safety and Efficacy of Tyroserleutide for Injection in Hepatocellular Carcinoma(HCC) Patients
- 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 investigation is a randomized, double-blind, placebo involved and multi-center clinical trial. All subjects are assigned to 4 groups, including 3mg, 6mg, 12mg per day and placebo group. Each group includes 25 subjects, who have hepatic-cellular carcinoma accompanied with branch vein thrombosis. They receive investigational drug 40 days after resection surgery. Each cycle lasts 4 to 6 days with an interval of 29 days in all 6 cycles.
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 |
|---|---|---|---|
| mitomycin, Fluorouracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Group 1
- description
- the Tyroserleutide for injection at the dosage of 3mg/d
- interventionNames
- Drug: mitomycin, Fluorouracil
- label
- Group 2
- description
- the Tyroserleutide for injection at the dosage of 6mg/d
- interventionNames
- Drug: mitomycin, Fluorouracil
- label
- Group 3
- description
- the Tyroserleutide for injection at the dosage of 12mg/d
- interventionNames
- Drug: mitomycin, Fluorouracil
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent 2. Age between 18 and 75 years 3. Hepatocellular Carcinoma accompanied with branch vein thrombosis 4. Carcinoma and bolt resection Integrity, cutting edge no tumor cells by microscopic lens in operation 5. CTA or MRI no Carcinoma and bolt after operation Exclusion Criteria: 1. hypersensitivity to the composition similarity of investigational drug 2. Concomitance other system primary tumor 3. surface area 1.47m2～1.92m2 4. HBV (-) and HCV(-) 5. Patients who have received resectional surgery for HCC 6. HCC complicating main portal vein cork 7. HCC complicating hepatic vein cork 8. Patients who have received systematicness therapy for HCC 9. Patients who have received immunoregulant 4 weeks before randomization 10. Concurrent participation in another clinical trial involving experimental treatment is excluded 4 weeks before randomization 11. uncontrolled infection, hemorrhage, guts leakage postoperative complications 12. postoperative liver function Child-pugh C 13. no evidence of extra-hepatic metastases postoperative 14. no utility sample for gene chip research 15. no physical examination, laboratory and imageology examination that baseline request
References
Publications (0)
Data not yet available