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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

Phase 2
18 Years
75 Years
Open (Enrolling)
Biliary Tract Cancer, Periampullary Adenocarcinoma, Pancreatic Cancer

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Trial Information

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

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

- 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,

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate for SOX sequential S-1

Outcome Description:

The primary endpoint is objective response rate,which equals CR+PR.

Outcome Time Frame:

1 years

Safety Issue:


Principal Investigator

Lin Shen, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beijing Cancer Hospital


China: Food and Drug Administration

Study ID:




Start Date:

July 2010

Completion Date:

July 2014

Related Keywords:

  • Biliary Tract Cancer
  • Periampullary Adenocarcinoma
  • Pancreatic Cancer
  • palliative chemotherapy
  • ORR
  • PFS
  • OS
  • safety
  • advanced Biliary Tract Carcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms
  • Biliary Tract Neoplasms