A Phase I study of tocilizumab plus gemcitabine/nab-paclitaxel in patient with gemcitabine/nab-paclitaxel-refractory metastatic pancreatic cancer

National Cancer Center Hospital East1 个研究点目标入组 15 人开始时间: 待定最近更新: 2022年5月27日

适应症

试验速览

暂无简介。

•Written informed consent for participation in the study is obtained at the discretion of the patient.
•Metastatic pancreatic cancer with histologically or cytologically confirmed diagnosis of adenocarcinoma
•Patients with progressed pancreatic cancer after treatment with GEM/nab-PTX achieved complete, partial response (PR) by the Response Evaluation Criteria in Solid Tumours (RECIST) guideline version 1.1, or equivanlent to PR (more than 20% tumor shrinkage or more than 50% reduction of tumor marker, such as CA19-9) for unresectable or recurrent pancreatic cancer
•GEM (750 mg/m2) and nabPTX (100 mg/m2) is judged to be tolerable when GEM/nabPTX is rechallenged
•Measurable disease based on RECIST version 1.
•serum CRP level >=0.5 to <10.0 mg/dL

•Severe effusion or edema
•Symptomatic brain metastasis
•Active concomitant malignancy
•Prior choledochojejunostomy
•Transfusion within 4 weeks before enrollment
•Major surgery excluding biliary drainage percutaneously or endoscopically within 4 weeks before enrollment
•Scheduled surgery during the study treatment
•Prior IL-6 signal blocker treatments including JAK inhibitors
•Prior immunotherapy including cancer vaccine, immune-checkpoint inhibitor, and so on
•Prior treatment with biologics including TCZ, trastuzumab, Infliximab, etanersept and adalimumab within 4 weeks before enrollment
•Active infectious diseases requiring systemic administration of antibiotics, antivirals, antifungals, etc.

safety - Frequency of adverse events - Occurrence of dose limiting toxicity

发起方

Loading locations...