Biliary Tract CancerPhase 2NCT01180153
Study of S-1 Oxaliplatin (SOX) for Biliary Tract Cancer (BTC) (Ampullary Adenocarcinoma)
A Phase 2 study testing S-1 oxaliplatin in people with Biliary Tract Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
To evaluate efficacy and safety of S-1 Oxaliplatin (SOX) regimen to patients with unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- S-1 oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Aug 2010to Aug 2012
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent has been signed by the subject itself;
- Aged over 18;
- With a definite pathological or cytological diagnosis of adenocarcinoma;
- No pre-treatment (including radiotherapy, chemotherapy, immunotherapy, etc.). For recurrent cases, if the subjects have received adjuvant chemotherapy without S-1 or L-OHP after surgery and the time to the end date of adjuvant chemotherapy is over 6 months, they can also be enrolled;
- Enhanced helical CT or MRI scanning shows a target lesion over 1cm within 14 days before enrollment
- Within 7 days before enrollment, baseline blood routine and biochemical indicators meet the following criteria:
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- Hemoglobin ≥ 90g/L,
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L,
- Platelets ≥ 100×109/L，
- Serum total bilirubin < 1.5 times of the upper normal limit,
- Serum creatinine < upper limit of normal,
- Serum albumin ≥ 30 g/L;
- Can receive oral administration;
- Karnofsky(KPS) score ≥ 70 points;
- Expected survival time is more than 90 days;
- Women of childbearing age must receive urine or blood pregnancy test within 7 days before randomization and the results are negative;
- Male and female patients of appropriate reproductive age are willing to use reliable contraception methods for contraception in the process of study till 30 days after drug withdrawal.
Who cannot join
- Patients with a severe drug allergy history (including mildly allergic to L-OHP, 5-FU, FT207, 5-HT3 receptor antagonist);
- Patients who participated or are participating in other clinical trials within 4 weeks before enrollment;
- Patients who have received blood transfusion, blood products and hematopoietic factor preparations such as G-CSF within 15 days before enrollment;
- Patients who have undergone a surgery within 15 days before enrollment, and its effects have not been eliminated;
- Patients with diarrhea;
- Patients with a complication of active infection (infection causes a fever above 38 ℃);
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- Patients accompanied by dysphagia, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding and perforation, etc. that cause difficulty in taking S-1 orally;
- Patients with severe liver disease (e.g. active hepatitis, cirrhosis, etc.), renal insufficiency, severe lung disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.), or uncontrollable diabetes, hypertension and other chronic systemic diseases;
- Patients who have received long-term systemic steroid therapy (Note: short-term users with steroid withdrawal > 2 weeks can be selected);
- Patients with brain metastases or suspected of brain metastases;
- Patients with peripheral nervous system disorder or a history of significant mental disorder and central nervous system disorder;
- Heart disease of significant clinical symptoms, e.g. congestive heart failure, coronary heart disease with significant symptoms, arrhythmia and hypertension that are difficult to be controlled by drugs, or with an episode of myocardial infarction within 6 months, or cardiac insufficiency;
- Patients with pleural effusion, ascites, or pericardial effusion that needs drainage;
- Pregnant or breast-feeding women, or male and female patients of appropriate reproductive age who refuse to take contraceptive measures;
- Patients who have suffered from other malignancies within 5 years, except basal cell carcinoma and carcinoma in situ of uterine cervix that have already been cured;
- Patients without legal capability, or who can not continue the study due to medical or ethical reasons;
- Patients who are determined not suitable to participate in this clinical trial by the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Chin Beijing Cancer Hospital
Beijing, Beijing Municipality, 100004
Jie Li, Doctor, 010-88121122 ext. 321, xiaotong10241@sin.com
Yi Shen, 010-59714220, ian97@163.com
About this study
Official title: An Pilot Study of S-1 Combined With Oxaliplatin for First-line Treatment of Unresectable, Metastatic or Locally Advanced Biliary Tract Cancer or Ampullary Adenocarcinoma
To evaluate efficacy and safety of S-1 Oxaliplatin (SOX) regimen to patients with unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma.
Read the detailed description
To list in cases with unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma that have not been treated before,confirm the efficacy and safety of combined S-1/L-OHP regimen for the biliary tract or ampullary carcinoma, providing evidence-based proof for the future treatment.
- Conditions
- Biliary Tract Cancer
- Being tested
- S-1 oxaliplatin
- Keywords
- 40 S-1/L-OHP, biliary tract, ampullary carcinoma
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1 oxaliplatinDrug
Also called S-1 (20mg, 25mg); L-OHP (50 mg)
S-1 (20mg, 25mg); L-OHP (50 mg)
| Study group | Role | What they receive |
|---|---|---|
| SOX: advanced BTC or ampullary carcinoma | Experimental | unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma receive SOX regimen Receives: Drug: S-1 oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
to evaluate objective response rate (ORR) of SOX regimen to BTC (Ampullary Adenocarcinoma)
Measured: 2 years
Secondary outcomes (1)
overall survival
to evaluate survival data of overall survival (OS),Progression free Survival(PFS), safety outcome of SOX regimen to BTC (Ampullary Adenocarcinoma)
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 posted12 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (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.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Investigators
- Lin Shen, Professor, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180153
- Sponsor's protocol ID
- ChinaBJCH_SOX_BTC
- Status last verified
- Aug 2010
- First submitted
- 9 Aug 2010
- Last updated
- 12 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Pilot Study of S-1 Combined With Oxaliplatin for First-line Treatment of Unresectable, Metastatic or Locally Advanced Biliary Tract Cancer or Ampullary Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01180153
- Acronym / sponsor ID
- ChinaBJCH_SOX_BTC
- Conditions
- Biliary Tract Cancer
- Keywords
- 40 S-1/L-OHP, biliary tract, ampullary carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 12 Aug 2010 (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.
To evaluate efficacy and safety of S-1 Oxaliplatin (SOX) regimen to patients with unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma.
Detailed description
To list in cases with unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma that have not been treated before,confirm the efficacy and safety of combined S-1/L-OHP regimen for the biliary tract or ampullary carcinoma, providing evidence-based proof for the future treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOX: advanced BTC or ampullary carcinoma | Experimental | Drug: S-1 oxaliplatinunresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma receive SOX regimen |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Informed consent has been signed by the subject itself;
- Aged over 18;
- With a definite pathological or cytological diagnosis of adenocarcinoma;
- No pre-treatment (including radiotherapy, chemotherapy, immunotherapy, etc.). For recurrent cases, if the subjects have received adjuvant chemotherapy without S-1 or L-OHP after surgery and the time to the end date of adjuvant chemotherapy is over 6 months, they can also be enrolled;
- Enhanced helical CT or MRI scanning shows a target lesion over 1cm within 14 days before enrollment
Key exclusion criteria (17 listed)
- Patients with a severe drug allergy history (including mildly allergic to L-OHP, 5-FU, FT207, 5-HT3 receptor antagonist);
- Patients who participated or are participating in other clinical trials within 4 weeks before enrollment;
- Patients who have received blood transfusion, blood products and hematopoietic factor preparations such as G-CSF within 15 days before enrollment;
- Patients who have undergone a surgery within 15 days before enrollment, and its effects have not been eliminated;
- Patients with 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 |
|---|---|---|
| S-1 oxaliplatinAlso: S-1 (20mg, 25mg); L-OHP (50 mg)S-1 (20mg, 25mg); L-OHP (50 mg) | Drug | SOX: advanced BTC or ampullary carcinoma |
Primary outcome
objective response rate
Time frame: 2 years
to evaluate objective response rate (ORR) of SOX regimen to BTC (Ampullary Adenocarcinoma)
1 secondary outcome
overall survival
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 12 Aug 2010.
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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, Professor 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 S-1 oxaliplatin in people with Biliary Tract Cancer, run by Peking University Cancer Hospital & Institute 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 17 inclusion and 17 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 12 Aug 2010. 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 Jie Li, Doctor (010-88121122 ext. 321, xiaotong10241@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: 2 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 12 Aug 2010.