SOX Sequential S-1 in Advanced Biliary Tract Carcinoma(BTC)and Pancreatic Cancer (NCT01811277) | Clinical Trial Compass
UnknownPhase 2
SOX Sequential S-1 in Advanced Biliary Tract Carcinoma(BTC)and Pancreatic Cancer
China40 participantsStarted 2010-07
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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
* 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 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:
* Known sensitivity to 5-HT3 antagonist and hypersensitivity to the other treatment agents including irinotecan, cisplatin and octreotide lar
* Any participati…