Malignancies Multiple Clinical Trial
Official title:
Anti-PD-1 Antibody Alone or in Combination With Low-dose Decitabine and/or Chemotherapy in Relapsed or Refractory Malignancies: an Open-label Phase I/II Trial
The purpose of this study is to assess the feasibility, safety, and efficacy of anti-PD-1 antibody alone or in combination with low-dose decitabine in patients with relapsed or refractory malignancies, including Non-Hodgkin'lymphoma, Hodgkin'lymphoma, gastrointestinal cancers, hepatocellular carcinoma, breast cancer, ovarian cancer or lung cancer or renal-cell cancer or pancreatic cancer or bile duct cancer.
Primary objective: To assess the feasibility and safety for Anti-PD-1 antibody alone or in
combination with decitabine and/or chemotherapy administered every 3 weeks to subjects with
relapsed or refractory malignancies.
Secondary objectives: 1) To assess the antitumor activity of Anti-PD-1 antibody alone or in
combination with decitabine and/or chemotherapy in subjects with relapsed or refractory
malignancies. 2) To characterize the immunological effects of Anti-PD-1 antibody alone or in
combination with decitabine and/or chemotherapy. 3) To characterize the immunological effects
of Anti-PD-1 antibody alone or in combination with decitabine and/or chemotherapy.
Exploratory objectives: 1) To analysis of potential biological parameters correlated to
clinical response and toxicities. 2) To search predictive biomarkers to guide the choose of
patients undergoing the treatment of Anti-PD-1 antibody alone or in combination with
decitabine and/or chemotherapy.
Safety Evaluation: Adverse events will be assessed continuously during the study and for 100
days post last treatment, and will be evaluated according to the NCI CTCAE Version 4.0.
Efficacy Evaluation: 1) Treatment response to lymphoma was defined using the International
Workshop to Standardize Response Criteria for Lymphomas; 2) Treatment response to solid
tumors was defined using Response Evaluation Criteria in Solid Tumors (RECIST1.1).
evaluation index: BOR; ORR; PFS and OS.
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