Clinical trial · Interventional
S-1/LV One Week on and One Week Off Regimen in Advanced Hepatocellular Carcinoma (HCC)
Phase II Study of S-1 Combined With Calcium Folinate to Treat Advanced Hepatocellular Carcinoma
NCT01533324CI-TRIAL-00006265unknownPhase 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)
S-1 is a new chemotherapy drug. Some phase II trials showed S-1 is effective in Hepatocellular Carcinoma (HCC). S-1 combined with calcium folinate (SL) showed very good efficiency and safety in colorectal cancer (CRC). The short duration (two weekly regimen) is better than common course 4 week regimen in tolerance. So the investigators want to examine the efficiency and safety of SL one week on and one week off regimen in HCC.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S-1 combined with Leucovorin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- S-1 combined with LV
- description
- S-1 combined with LV
- interventionNames
- Drug: S-1 combined with Leucovorin
Primary outcomes (1)
- measure
- DCR
- timeFrame
- in two years
- description
- DCR means patient got the best reaction and last for more than 4 weeks DCR=（CR）+ （PR）+ （SD） by RESIST 1.1
Secondary outcomes (3)
- measure
- TTP ( time to progression)
- timeFrame
- in 2 years
- description
- from enrolled to progression(iconography).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female, 70 years \> Age \> 18 years * Patient with unresectable primary hepatocellular carcinoma * Child-Pugh Class A or B, without ascites * ECOG score 0 * At least one tumor nodule can be evaluated by CT or MRI * Can take medicine orally * Expected survival time not less than 12 weeks * Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to enrolling in this portion of the study During the trial and 4 week after the trial, must take contraception * Patients must be: * Hemoglobin \> 9.0g/dl * ANC \> 1.5×109/L * Platelet ≥ 60×109/L * Total bilirubin \< 3mg/dl * ALT or AST \< 5 X ULN * ALP \< 4 X ULN * PT-INR \< 2.3 * Patients who is taking Warfarin , should be tested every week till getting stable INR * Serum creatinine \< 1.5 X ULN * Serum amylase and lipase \< 2 X ULN Exclusion Criteria: * Known or suspected allergy to any agent given in association with this trial * Local treatment within 4 weeks prior to start of study drug * History of any heart disease * History of HIV infection except for HBV and HCV * Active clinically serious infections (\> 2 NCI-CTC Version 3.0) * Clinically significant gastrointestinal bleeding within 4 weeks prior to study entry. * Embolization or infarction such as transient ischemic disease, deep vein thrombosis, pulmonary embolization within 6 months prior to study entry * Previous malignancy (except for cervical carcinoma in situ, adequate treated basal cell carcinoma, or superficial bladder tumors \[Ta, Tis and T1\], early gastric cancer, or other malignancies curatively treated \> 3 years prior to entry * Extrahepatic tumor spread which affects patient's prognosis, such as bony metastasis or brain metastasis * Hydrothorax， ascites and hydropericardium need to drain * Serious diarrhea * Combined with serious pulmonary diseases, such as interstitial pneumonia, pulmonary fibrosis and serious pulmonary emphysema * Serious complication,such as intestinal obstruction,renal insufficiency, hepatic insufficiency and cerebrovascular disorders * Pregnant or breast-feeding * Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment. * Gastrointestinal disease that may affect to the absorption of drug or pharmacokinetics. * Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study * Patients unable to swallow oral medications.
References
Publications (0)
Data not yet available
No reference posted for this study.