Clinical trial · Interventional
UFUR Plus Thalidomide for Advanced Hepatocellular Carcinoma
A Phase II Study of Tegafur/Uracil(UFUR) Plus Thalidomide for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma (HCC)
- 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)
We hypothesize that combination of tegafur/uracil(UFUR) and thalidomide, both of which have been shown to be active in some HCC patients,may be a highly useful regimen for the treatment of advanced HCC. There are several rationales underlying this combination. First, anti-angiogenesis therapy may improve the efficacy of chemotherapy by normalizing the abnormal vasculature in tumors, and thus improving the delivery of chemotherapeutic agents to the tumor cells. Second, chemotherapeutic drugs given in a low-dose, un interrupted, and protracted way can induce anti-tumor effect through the anti-angiogenesis activity (so-called"metronomic chemotherapy"). The efficacy of metronomic chemotherapy can be suppressed by VEGF/VEGFR signaling pathways and thus can bo further potentiated by agents blocking those survival signals of endothelial cell. In this regard, tegafur/uracil appears to be a good candidate for metronomic chemotherapy because tegafur/uracil and its metabolites bave already been shown to inhibit angiogenesis in several pre-clinical models.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tegafur/Uracil | Drug | Tegafur | ALIAS |
| Thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Thalidomide plus Tegafur/Uracil1
- description
- Thalidomide plus Tegafur/Uracil
- interventionNames
- Drug: Thalidomide
- Drug: Tegafur/Uracil
Primary outcomes (1)
- measure
- To evaluate the overall response rate of UFUR and thalidomide in the treatment of advanced HCC by RECIST criteria
- timeFrame
- Confirmed response within 4 weeks
Secondary outcomes (3)
- measure
- To determine the disease stabilization rate.
- timeFrame
- 2 to 3 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed HCC or HBC/HCV carrier with hepatic tumor of α-FP\>400 Stage IV dis. By AJCC KPS\>70% Age\>18 Liver function reserves:Child-Pugh Class A, ALT\<5xUNL, Bil-T\<1.5xUNL WBC\>4000 or ANC\>1500, PLT\>75K, Cr\<1.5xUNL Previous local therapy completed 6wks Exclusion Criteria: * Concurrent corticosteroids Previous exposure to C/T, Thalidomide CNS metastasis Concomitant illness: active infection, \>NCIG2 neuropathy, Hx of seizures Organ transplantation
References
Publications (0)
Data not yet available