Clinical trial · Interventional
Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma
Phase II Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma
NCT01429961CI-TRIAL-00005459unknownPhase 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)
Phase II trial of Palliative Chemotherapy with TS-1 and Oxaliplatin for Patients with Advanced Hepatocellular Carcinoma
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 |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SOX
- description
- TS-1, Oxaliplatin regimen (3week) Oxaliplatin 130 mg/m2 IV Day 1 S-1 40 mg/m2 b.i.d. Day1-14
- interventionNames
- Drug: SOX
Primary outcomes (1)
- measure
- Time to progression (TTP)
- timeFrame
- 2 years
- description
- The time from study enrollment to tumor progression or death
Secondary outcomes (3)
- measure
- overall survival
- timeFrame
- 2 years
- description
- overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * ECOG performance score of two or less * Child Pugh class A• * Histologically or cytologically confirmed HCC or clinical diagnosis of HCC when the following criteria are all met History of chronic hepatitis or cirrhosis of liver Typical features of HCC demonstrated in dynamic imaging studies, such as three phase computed tomography AFP level more than 200 ng/mL * presence of extrahepatic measurable lesion * no prior systemic therapy (excluding sorafenib) * adequate marrow, liver, kidney function * written informed consent Exclusion Criteria: * prior systemic therapy (excluding sorafenib) * hypersensitivity to study drugs * active gastrointestinal bleeding * other malignancies within five years * pregnant or breastfeeding female * symptomatic brain or leptomeningeal metastasis * clinically significant heart disease * interstitial pneumonia * peripheral neuropathy grade one or more * uncontrolled infection * renal impairment * prior use of investigational drug or therapy within 4 weeks
References
Publications (1)
- DERIVEDLee DW, Lee KH, Kim HJ, Kim TY, Kim JS, Han SW, Oh DY, Kim JH, Im SA, Kim TY. A phase II trial of S-1 and oxaliplatin in patients with advanced hepatocellular carcinoma. BMC Cancer. 2018 Mar 5;18(1):252. doi: 10.1186/s12885-018-4039-9. PMID 29506478