Biliary Tract CancerPhase 2NCT01811277
SOX Sequential S-1 in Advanced Biliary Tract Carcinoma（BTC）and Pancreatic Cancer
A Phase 2 study testing SOX sequential S-1 in people with Biliary Tract Cancer and Periampullary Adenocarcinoma, run by Peking University at 1 site in China.
Trial summary
This is an exploratory, single-armed, open label study on the efficacy and safety of sequential S-1 therapy after SOX in unresectable metastatic or locally advanced biliary system or periampullary cancer or pancreatic cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Cancer, Periampullary Adenocarcinoma, Pancreatic Cancer
- What is being tested?
- SOX sequential S-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jul 2010to Jul 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written Informed consent
- Male or female patients >=18 years old
- Histologically or cytologically confirmed diagnosis of adenocarcinoma
- No previous treatment is allowed including chemotherapy, radiotherapy,immunotherapy or others.
- In case the patient received adjuvant therapy before, enrollment is allowed if the adjuvant therapy does not contain L-OHP or S-1 and at the same time, the last day of chemotherapy is ≥180 days before screening.
- Target lesion more than 1cm in diameter by enhanced CT or MRI 21 days before enrollment
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- The laboratory parameter meets the following criteria 7 days before enrollment
- Hemoglobin ≥90g/L
- Absolute neutrophil count≥1.5×10^9/L, platelets 100×10^9/L；
- ALT and AST≤2.5 ULN(in case of the patients with liver metastasis,ALT and AST≤5.0 ULN)
- ALP ≤2.5 ULN (in case of the patients with liver metastasis,≤5.0 ULN)
- Total Serum bilirubin ≤1.5 ULN
- Serum creatinine ≤1.0 ULN
- serum albumin(ALB)≥30g/L；
- can tolerate oral drug administration；
- KPS ≥70
- Estimated survival ≥90 days
- Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of enrollment and must be willing to use adequate methods of contraception during the study and for 30 days after last study durg administration.
Who cannot join
- Known sensitivity to 5-HT3 antagonist and hypersensitivity to the other treatment agents including irinotecan, cisplatin and octreotide lar
- Any participation in trials simultaneously or 4 weeks before screening.
- 15 days prior to enrollment, received a blood transfusion, blood products and hematopoietic growth factors such as G-CSF.
- Undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such surgery.
- Uncontrolled severe diarrhea
- Uncontrolled active infection (fever ≥38 degrees due to infection)
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- S-1 oral drug administration difficulty due to difficulty swallowing, complete or incomplete digestive tract obstruction, gastrointestinal active bleeding, perforation;
- severe hepatopathy including active hepatitis and hepatic cirrhosis, renal dysfunction, severe pulmonary diseases including interstitial pneumonia, pulmonary fibrosis and severe pulmonary emphysema, uncontrolled diabetes, hypertension and other chronic systematic diseases.
- Chronic treatment with steroids.(In case of the patients with short-term use of steroids, the enrollment is permitted if the administration is stopped 2 weeks before screening.)
- confirmed or suspected CNS metastasis
- the history of peripheral nervous system impairment, obvious mental disorder or CNS impairment
- clinically significant heart disease, including congestive heart failure, symptomatic coronal heart disease, arrythmia uncontrolled by medication and acute myocardial infarction or cardiac insufficiency within 6 months before screening
- Drainage of pleural effusion, peritoneal effusion and pericardial effusion
- pregnant women or women in lactation period
- Fertile male or women of child-bearing potential refuse to take highly effective methods of birth control
- Incidence of other second primary malignant tumors within 5 years, except for cured basal cell carcinoma and cervical carcinoma in situ.
- patients of legal incapacity or who have the potential of influence the whole trial due to medical or ethic reasons.
- Other patients who are not eligible to the trial under investigators' discretion
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, Prof., +86 10 88196175, lin100@medmail.com.cn
Jie Li, Prof., +86 10 88196561, xiaotong10241@sina.com
About this study
Official title: Phase II Exploratory Study of S-1 Combined With Oxaliplatin Sequential S-1 Single-agent First-line Treatment of Unresectable Metastatic or Locally Advanced Biliary System, Periampullary Cancer and Pancreatic Cancer
This is an exploratory, single-armed, open label study on the efficacy and safety of sequential S-1 therapy after SOX in unresectable metastatic or locally advanced biliary system or periampullary cancer or pancreatic cancer patients. The primary endpoint is Objective response rate and secondary endpoint is progression free survival , overall survival ,1 year survival rate and safety.
- Being tested
- SOX sequential S-1
- Keywords
- palliative chemotherapy, ORR, PFS, OS, safety, advanced Biliary Tract Carcinoma
- Medical subject headings
- Biliary Tract Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOX sequential S-1Drug
Also called S-1/oxaliplatin
4-6 cycles SOX followed by S-1 monotherapy until disease progression
S-1: 40~60mg bid，po, d1~14 （S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid） oxaliplatin：130mg/m2，iv drip for 2h，d1
| Study group | Role | What they receive |
|---|---|---|
| SOX sequential S-1 | Experimental | 4-6 cycles of SOX followed by S-1 monotherapy until disease progression Receives: Drug: SOX sequential S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate for SOX sequential S-1
The primary endpoint is objective response rate,which equals CR+PR.
Measured: 1 years
Secondary outcomes (4)
Overall Survival
OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost
Measured: 2 years
progression free survival
PFS means that from the first dose of treatment drug to disease progression or death or lost, the follow-up visit will be performed every 6 weeks till progression or death or lost
Measured: 1 year
1 year survival rate
the follow-up visit of survival will be performed every 3 months till 1 year
Measured: 1 year
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startJul 2010
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Shen Lin, Peking University
- Investigators
- Lin Shen, Prof., Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811277
- Sponsor's protocol ID
- SOX-S-1 BTC
- Status last verified
- Jul 2010
- First submitted
- 11 Mar 2013
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Exploratory Study of S-1 Combined With Oxaliplatin Sequential S-1 Single-agent First-line Treatment of Unresectable Metastatic or Locally Advanced Biliary System, Periampullary Cancer and Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01811277
- Acronym / sponsor ID
- SOX-S-1 BTC
- Keywords
- palliative chemotherapy, ORR, PFS, OS, safety, advanced Biliary Tract Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Study start
- Jul 2010
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 14 Mar 2013 (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.
This is an exploratory, single-armed, open label study on the efficacy and safety of sequential S-1 therapy after SOX in unresectable metastatic or locally advanced biliary system or periampullary cancer or pancreatic cancer patients. The primary endpoint is Objective response rate and secondary endpoint is progression free survival , overall survival ,1 year survival rate and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOX sequential S-1 | Experimental | Drug: SOX sequential S-14-6 cycles of SOX followed by S-1 monotherapy until disease progression |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Written Informed consent
- Male or female patients >=18 years old
- Histologically or cytologically confirmed diagnosis of adenocarcinoma
- No previous treatment is allowed including chemotherapy, radiotherapy,immunotherapy or others.
- In case the patient received adjuvant therapy before, enrollment is allowed if the adjuvant therapy does not contain L-OHP or S-1 and at the same time, the last day of chemotherapy is ≥180 days before screening.
Key exclusion criteria (18 listed)
- Known sensitivity to 5-HT3 antagonist and hypersensitivity to the other treatment agents including irinotecan, cisplatin and octreotide lar
- Any participation in trials simultaneously or 4 weeks before screening.
- 15 days prior to enrollment, received a blood transfusion, blood products and hematopoietic growth factors such as G-CSF.
- Undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such surgery.
- Uncontrolled severe diarrhea
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 |
|---|---|---|
| SOX sequential S-1Also: S-1/oxaliplatin4-6 cycles SOX followed by S-1 monotherapy until disease progression S-1: 40~60mg bid，po, d1~14 （S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid） oxaliplatin：130mg/m2，iv drip for 2h，d1 | Drug | SOX sequential S-1 |
Primary outcome
Objective response rate for SOX sequential S-1
Time frame: 1 years
The primary endpoint is objective response rate,which equals CR+PR.
4 secondary outcomes
Overall Survival
Time frame: 2 years
progression free survival
Time frame: 1 year
1 year survival rate
Time frame: 1 year
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2013.
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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.
Lin Shen, Prof. principal investigator
Peking University Cancer Hospital & Institute
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 SOX sequential S-1 in people with Biliary Tract Cancer and Periampullary Adenocarcinoma, run by Peking 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 18 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 Mar 2013. 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 Lin Shen, Prof. (+86 10 88196175, lin100@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate for SOX sequential S-1 (time frame: 1 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 Mar 2013.