Status:
UNKNOWN
SOX Sequential S-1 in Advanced Biliary Tract Carcinoma（BTC）and Pancreatic Cancer
Lead Sponsor:
Peking University
Collaborating Sponsors:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Biliary Tract Cancer
Periampullary Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 can...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01811277
Start Date
July 1 2010
End Date
July 1 2014
Last Update
March 15 2013
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142