Unresectable Advanced and Recurrent Biliary Tract Cancer
Conditions
Interventions
OTS102 1mL will be administered by subcutaneous injection on days,1,8,15 and 22 of each 28-day treatment cycles. Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on days,1,
Sponsors
Oncotherapy science,Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Diagnosed as biliary tract cancer which includes intrahepatic cholangiocarcinoma,extrahepatic cholangiocarcinoma,gallbladder cancer, ampulla of vater cancer,and histologically confirmed as adenocarcinoma or squamous cell carcinoma. 2)Advanced unresectable biliary tract cancer and recurrent biliary tract cencer. Having of measurable lesions must not be required. Presence/absence of measurable lesions is not considered, but confirm by diagnostic imaging test within 21 days before enrollment. 3)Patients must have human leukocyte antigen(HLA)-A*2402 4)Patients must be >=20 years old and <75 years old at the time of obtaining informed consent. 5)ECOG Performance Status must be 0 or 1. 6)Life Expectancy must be >=3 months. 7)The following criteria must be satisfied in laboratory tests conducted within 21 days befor resigtration.And G-CSF,Erythropoetin,Blood products and transfusion must be untried within 2weeks before it inspects. -White blood cell count >= 3,500 /mm3, <=12,000/mm3 -Neutrophil count >=2,000 /mm3 -Hemoglobin >=9.0 g/dL -Platelet count >=100,000 /mm3 -Total bilirubin <=2.0 mg/dL(to be permitted <3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice.Consecutive measurements of two times must fill this criteria. ) -AST <=150 IU/L -ALT <=150 IU/L -Serum Creatinine <=1.5 mg/dL 8)When the adjuvant therapy is enforced to biliary tract cancer,the use medicine is TS-1.The final administering day must be conducted at least 6 months before enrollment. 9)Patients with no previous treatment (radiotherapy, chemotherapy, etc.) for biliary tract cancer, except resection. 10)Laparotomy must be conducted at least 2 weeks before enrollment.*8)of chemotherapies is excluded. 11)Voluntarily signed the written consent form.
Exclusion criteria
Exclusion criteria: 1)Prior treatment of OTS102 or KDR169. 2)Double cancer except carcinoma in situ or intramucosal cancer (history is contained). 3)Pancreatic cancer infiltrated into digestive tract with serious concern of bleeding. 4)cerebral metastasis is doubted. 5)Pleural effusion, ascites fluid, pericardial fluid and peritoneal dissemination. 6)Active infections (excluding hepatitis B and C). 7)Severe liver disorder or renal disorder, equivalent to CTCAE grade3 or greater. 8)Severe nervous disorder or mental disorder. 9)Uncontrolled diabetes mellitus. 10)Intestinal tract paralysis or possible. 11)Chronic and systemic treatment of steroid. 12)Interstitial pneumonia or pulmonary fibrosis (to be confirmed by chest X-ray within 21 days before enrollment). 13)History of myocardial infarction or brain infarction within 6 months before registration. 14)Evidence of bleeding diathesis or severe coagulopthy, or patients with those histories. 15)Need continuous medication of anticoagulant drug except aspirin 16)Uncontrolled hypertenstion. 17)Arrhythmia or heart failure that needs treatment. 18)Other serious complication. 19)Pregnant females or nursing mothers who can not stop lactation after the recruitment. Patients or partners, who don't attempt to doing contraception or lactation during the study period 20)Current paticipation in other drug clinical trials. (excluding the study, which doesn't need intervention) 21)As determined by the principal investigator or the sub-investigator the subject are not adequate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival(OS) | — |
Countries
Japan
Outcome results
None listed