Clinical trial · Interventional
Safety and Efficacy of GSMs-TACE Combined With Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm)
Safety and Efficacy of GSMs-TACE Combined With Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm): A Single Center, Open, Randomized Controlled Trial.
NCT04619329CI-TRIAL-00048541unknownN/AClinicalTrials.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)
A Single center, Open, Randomized Controlled Trial Evaluating the Safety and Efficacy of GSMs-TACE combined with Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm).
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 |
|---|---|---|---|
| Huge Hepatocellular Carcinoma (HCC) (≥10cm) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GSMs-TACE | Device | — | UNRESOLVED |
| Surgical Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- GSMs-TACE+ Surgical Resection Group
- description
- After TACE using Lobaplatin and GSMs (150-350μm, 350-560μm, 560-710μm or 710-1000μm), patients will receive surgical resection 15-30 days later, as specified per protocol.
- interventionNames
- Device: GSMs-TACE
- Procedure: Surgical Resection
- type
- ACTIVE_COMPARATOR
- label
- Surgical Resection Group
- description
- Patients will receive surgical resection, as specified per protocol.
- interventionNames
- Procedure: Surgical Resection
Primary outcomes (2)
- measure
- Disease Free Survival(DFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Confirmed imaging and pathological diagnosis of HCC, or diagnosed for the first time according to the guidelines for diagnosis and treatment of primary liver cancer in China (2019 edition). 2. Barcelona Clinic Liver Cancer (BCLC) stage A or B. 3. Remnant liver volume and liver function reserve are suitable for surgical resection. 4. Main lesion diameter ≥10cm. 5. Number of HCC lesions ≤5 and all located on one liver lobe. 6. Liver function Child-Pugh class A 7. ECOG Performance Status 0-1 8. Life expectancy ≥ 6 months 9. HCC is diagnosed for the first time. 10. Age 18 to 75 years 11. Able to sign and provide written informed consent. Exclusion Criteria: 1. Severe active infection \>grade 2 (except for Hepatitis B and C infection). 2. Liver function Child-Pugh class C. 3. BCLC stage C. 4. Patients with unresectable HCC. 5. Platelet \<60×109/L. 6. Concomitant malignant tumors in other organs. 7. Patient with severe cardiac, lung or kidney disease, or severe diabetes. 8. Pregnant or breast-feeding woman. 9. Patients with severe neuropathy and unable to report therapeutic effects. 10. Patients with severe atherosclerosis. 11. Patients with AIDS. 12. Severe hemorrhage of digestive tract within the 4 weeks prior to enrolment. 13. Severe thrombogenesis or embolic event within the 6 months prior to enrolment. 14. Currently enrolled or going to enroll in any other clinical trials. 15. Subject is not suitable to participate in the study as judged by investigator (poor patient compliance,inability to follow up).
References
Publications (0)
Data not yet available
No reference posted for this study.