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SOX Sequential S-1 in Advanced Biliary Tract Carcinoma(BTC)and Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01811277
Recruitment Status : Unknown
Verified July 2010 by Shen Lin, Peking University.
Recruitment status was:  Recruiting
First Posted : March 14, 2013
Last Update Posted : March 15, 2013
Taiho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Shen Lin, Peking University

Brief 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. The primary endpoint is Objective response rate and secondary endpoint is progression free survival , overall survival ,1 year survival rate and safety.

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Periampullary Adenocarcinoma Pancreatic Cancer Drug: SOX sequential S-1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2010
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arm Intervention/treatment
Experimental: SOX sequential S-1
4-6 cycles of SOX followed by S-1 monotherapy until disease progression
Drug: SOX sequential S-1

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

Other Name: S-1/oxaliplatin

Primary Outcome Measures :
  1. Objective response rate for SOX sequential S-1 [ Time Frame: 1 years ]
    The primary endpoint is objective response rate,which equals CR+PR.

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 2 years ]
    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

  2. progression free survival [ Time Frame: 1 year ]
    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

  3. 1 year survival rate [ Time Frame: 1 year ]
    the follow-up visit of survival will be performed every 3 months till 1 year

  4. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 2 years ]
    participants will be followed for the duration of hospital stay, an expected average of 3 weeks

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01811277

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Contact: Lin Shen, Prof. +86 10 88196175
Contact: Jie Li, Prof. +86 10 88196561

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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Lin Shen, Prof.    +86 10 88196175   
Contact: Jie Li, Prof.    +86 10 88196561   
Sponsors and Collaborators
Peking University
Taiho Pharmaceutical Co., Ltd.
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Principal Investigator: Lin Shen, Prof. Beijing Cancer Hospital
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Responsible Party: Shen Lin, Head of GI Cancer department, Peking University Identifier: NCT01811277    
Other Study ID Numbers: SOX-S-1 BTC
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: March 15, 2013
Last Verified: July 2010
Keywords provided by Shen Lin, Peking University:
palliative chemotherapy
advanced Biliary Tract Carcinoma
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Diseases
Antineoplastic Agents