A Phase 1/2 interventional study of Anti-PD-1 antibody and Decitabine in Malignancies Multiple, sponsored by Han weidong. Recruiting at 1 site in China. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by Han weidong · Phase 1/2, Interventional, and Treatment
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.
4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.
This study's planned enrollment of 250 is above the median of 50 across 3,374 interventional studies indexed under Recurrence.
Browse Recurrence studies →Han weidong is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects must have adequate bone marrow, live, renal, lung and heart functions.
Exclusion Criteria:
Decitabine will be administrated at 10mg/d on day1 to 5, followed by Anti-PD-1 antibody 200mg on day8 IV Q3 weeks until progression.
Drug: Anti-PD-1 antibody · Drug: Decitabine
Anti-PD-1 antibody 200mg IV Q3 weeks until progression.
Drug: Anti-PD-1 antibody
Chemotherapy will be given depends on the cancer type and treatment regimen before enrollment. Chemotherapy was administrated on day1 , followed by Anti-PD-1 antibody 200mg on day2 IV Q3 weeks until progression. Following disease remission, radiotherapy could be administered or omitted for consolidation at the discretion of the investigator.
Drug: Anti-PD-1 antibody · Drug: Chemotherapy
Anti-PD-1 antibody will be given at 1-3mg/kg on day8 by IV every three weeks
Decitabine will be given at 10mg/d on day 1to 5 by IV every three weeks
Chemotherapy be given depends on the cancer type and treatment regimen before enrollment.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: 2 years
Objective response by Response Evaluation Criteria in Solid Tumors (RECIST1.1).
Time frame: 3 years
Objective response by the International Workshop to Standardize Response Criteria for lymphomas.
Time frame: 3 years
Progression free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
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