Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
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 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
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
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Central trial contact
Jie Li, Prof.; Lin Shen, Prof.
Data sourced from clinicaltrials.gov
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