Brief Title
SOX Sequential S-1 in Advanced Biliary Tract Carcinoma（BTC）and Pancreatic Cancer
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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective response rate for SOX sequential S-1
Secondary Outcome
Overall Survival
Condition
Biliary Tract Cancer
Intervention
SOX sequential S-1
Study Arms / Comparison Groups
SOX sequential S-1
Description: 4-6 cycles of SOX followed by S-1 monotherapy until disease progression
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
40
Start Date
July 2010
Completion Date
July 2014
Primary Completion Date
July 2014
Eligibility Criteria
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
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Lin Shen, Prof., +86 10 88196175, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01811277
Organization ID
SOX-S-1 BTC
Responsible Party
Principal Investigator
Study Sponsor
Peking University
Collaborators
Taiho Pharmaceutical Co., Ltd.
Study Sponsor
Lin Shen, Prof., Principal Investigator, Beijing Cancer Hospital
Verification Date
July 2010