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

Study Overview

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

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.

N/A

Biliary Tract Cancer
Periampullary Adenocarcinoma
Pancreatic Cancer

DRUG: SOX sequential S-1

SOX-S-1 BTC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-03-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-03-13
First Submitted that Met QC Criteria 2013-03-12	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-03-15
First Posted (ESTIMATED) 2013-03-14	Results First Posted N/A	Last Verified 2010-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/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

Participant Group/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

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

Secondary Outcome Measures	Measure Description	Time Frame
Overall Survival	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 years
progression free survival	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	1 year
1 year survival rate	the follow-up visit of survival will be performed every 3 months till 1 year	1 year
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	participants will be followed for the duration of hospital stay, an expected average of 3 weeks	2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Lin Shen, Prof.

Phone Number: +86 10 88196175

Email: lin100@medmail.com.cn

Study Contact Backup

Name: Jie Li, Prof.

Phone Number: +86 10 88196561

Email: xiaotong10241@sina.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Taiho Pharmaceutical Co., Ltd.

Investigators

PRINCIPAL_INVESTIGATOR: Lin Shen, Prof., Peking University Cancer Hospital & Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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