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| Name | Class |
|---|---|
| Taiho Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOX sequential S-1 | Experimental | 4-6 cycles of SOX followed by S-1 monotherapy until disease progression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOX sequential S-1 | Drug | 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 |
| 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 |
| 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 |
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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
can tolerate oral drug administrationï¼›
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Shen, Prof. | Contact | +86 10 88196175 | lin100@medmail.com.cn | |
| Jie Li, Prof. | Contact | +86 10 88196561 | xiaotong10241@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Lin Shen, Prof. | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
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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 |
| D004066 |
| Digestive System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |