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
- 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
- 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
- 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
- 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.
- 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,
- 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
- confirmed or suspected CNS metastasis
- the history of peripheral nervous system impairment, obvious mental disorder or CNS
- 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