CarcinomaPhase 2NCT01533324
S-1/LV One Week on and One Week Off Regimen in Advanced Hepatocellular Carcinoma (HCC)
A Phase 2 study testing S-1 combined with Leucovorin in people with Carcinoma and Liver Diseases, run by Second Military Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carcinoma, Liver Diseases, Hepatocellular Carcinoma
- What is being tested?
- S-1 combined with Leucovorin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, 200438
Xie Feng, attending physician, +8613386272885, hunanxiefeng@yahoo.com.cn
Xie Feng, attending physician
About this study
Official title: Phase II Study of S-1 Combined With Calcium Folinate to Treat Advanced Hepatocellular Carcinoma
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.
Read the detailed description
S-1 is a new chemotherapy drug. Some phase II trials showed S-1 is effective in HCC. S-1 combined with calcium folinate (SL) showed very good efficiency and safety in 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.
SL one week on and one week off regimen will be give to advanced HCC patients. The primary endpoint is durable complete response (DCR).
- Conditions
- Carcinoma, Liver Diseases, Hepatocellular Carcinoma
- Being tested
- S-1 combined with Leucovorin
- Keywords
- hepatocellular carcinoma, S-1, Leucovorin, fluorouracil
- Medical subject headings
- Carcinoma, Liver Diseases, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1 combined with LeucovorinDrug
Also called TS-1, formyltetrahydrofolate
S-1 capsules 80mg/m2/d BID one week on and one week off Leucovorin tablets 50mg/d BID one week on and one week off
| Study group | Role | What they receive |
|---|---|---|
| S-1 combined with LV | Experimental | S-1 combined with LV Receives: Drug: S-1 combined with Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
DCR
DCR means patient got the best reaction and last for more than 4 weeks DCR=（CR）+ （PR）+ （SD） by RESIST 1.1
Measured: in two years
Secondary outcomes (3)
TTP ( time to progression)
from enrolled to progression(iconography).
Measured: in 2 years
OS ( overall survival)
to death
Measured: in two years
safety
any adverse reaction by NCI-CTCAE 3.0
Measured: in two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startNov 2011
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xie feng, Second Military Medical University
- Investigators
- Yang Jiamei, Chief, Study chair, Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533324
- Sponsor's protocol ID
- HCC-SL-2W
- Status last verified
- Feb 2012
- First submitted
- 10 Feb 2012
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of S-1 Combined With Calcium Folinate to Treat Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01533324
- Acronym / sponsor ID
- HCC-SL-2W
- Conditions
- Carcinoma, Liver Diseases, Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, S-1, Leucovorin, fluorouracil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Second Military Medical UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 15 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
S-1 is a new chemotherapy drug. Some phase II trials showed S-1 is effective in HCC. S-1 combined with calcium folinate (SL) showed very good efficiency and safety in 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.
SL one week on and one week off regimen will be give to advanced HCC patients. The primary endpoint is durable complete response (DCR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S-1 combined with LV | Experimental | Drug: S-1 combined with LeucovorinS-1 combined with LV |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-1 combined with LeucovorinAlso: TS-1, formyltetrahydrofolateS-1 capsules 80mg/m2/d BID one week on and one week off Leucovorin tablets 50mg/d BID one week on and one week off | Drug | S-1 combined with LV |
Primary outcome
DCR
Time frame: in two years
DCR means patient got the best reaction and last for more than 4 weeks DCR=（CR）+ （PR）+ （SD） by RESIST 1.1
3 secondary outcomes
TTP ( time to progression)
Time frame: in 2 years
OS ( overall survival)
Time frame: in two years
safety
Time frame: in two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Jiamei, Chief study chair
Second Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-1 combined with Leucovorin in people with Carcinoma and Liver Diseases, run by Second Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xie Feng, physician (+8613386272885, hunanxiefeng@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DCR (time frame: in two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2012; AzTrials last refreshed its copy on 1 Nov 2026.