Anti-PD-1 Antibody Alone or in Combination With Decitabine/Chemotherapy in Relapsed or Refractory Malignancies
NCT ID: NCT02961101
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
250 participants
INTERVENTIONAL
2016-05-31
2026-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Anti-PD-1 antibody+decitabine
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.
Anti-PD-1 antibody
Anti-PD-1 antibody will be given at 1-3mg/kg on day8 by IV every three weeks
Decitabine
Decitabine will be given at 10mg/d on day 1to 5 by IV every three weeks
Anti-PD-1 antibody
Anti-PD-1 antibody 200mg IV Q3 weeks until progression.
Anti-PD-1 antibody
Anti-PD-1 antibody will be given at 1-3mg/kg on day8 by IV every three weeks
Anti-PD-1 antibody+chemotherapy
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.
Anti-PD-1 antibody
Anti-PD-1 antibody will be given at 1-3mg/kg on day8 by IV every three weeks
Chemotherapy
Chemotherapy be given depends on the cancer type and treatment regimen before enrollment.
Interventions
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Anti-PD-1 antibody
Anti-PD-1 antibody will be given at 1-3mg/kg on day8 by IV every three weeks
Decitabine
Decitabine will be given at 10mg/d on day 1to 5 by IV every three weeks
Chemotherapy
Chemotherapy be given depends on the cancer type and treatment regimen before enrollment.
Eligibility Criteria
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Inclusion Criteria
2. 12 to 75 years of age.
3. ECOG performance of less than 2.
4. Life expectancy of at least 3 months.
5. Subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria; with solid tumors must have at least one measureable lesion \>1 cm per RECIST1.1.
6. Subjects must have received at least two prior chemotherapy regimen, and must be off therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.
7. Subjects must have adequate bone marrow, live, renal, lung and heart functions.
1. Absolute neutrophil count greater than or equal to 1,000/μL.
2. Platelet count greater than or equal to 70,000/µL.
3. Serum bilirubin level less than or equal to 1.5 x upper limits of normal (ULN).
4. Serum creatinine less than or equal to 1.5 x ULN.
5. Alanine aminotransferase \[ALT or SGPT\] and aspartate aminotransferase \[AST or SGOT\] less than or equal to 2.5 x ULN.
Exclusion Criteria
2. Serious uncontrolled medical disorders or active infections, pulmonary and intestinal infection especially.
3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .
4. Prior organ allograft.
5. Women who are pregnant or breastfeeding.
6. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
12 Years
75 Years
ALL
No
Sponsors
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Han weidong
OTHER
Responsible Party
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Han weidong
Principal Investigator
Principal Investigators
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Chunmeng Wang, Master
Role: STUDY_DIRECTOR
Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
Wenying Zhang, Master
Role: STUDY_DIRECTOR
Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
Yang Liu, Doctor
Role: STUDY_DIRECTOR
Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
Meixia Chen, Doctor
Role: STUDY_DIRECTOR
Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
Yan Zhang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
Qian Mei, Doctor
Role: STUDY_DIRECTOR
Department of Molecular Biology, Institute of Basic Medicine, Chinese PLA General Hospital, Beijing, 100853, China.
Jing Nie, Doctor
Role: STUDY_DIRECTOR
Department of Molecular Biology, Institute of Basic Medicine, Chinese PLA General Hospital, Beijing, 100853, China.
Xiang Li, Master
Role: PRINCIPAL_INVESTIGATOR
Department of Molecular Biology, Institute of Basic Medicine, Chinese PLA General Hospital, Beijing, 100853, China.
Liang Dong, Master
Role: PRINCIPAL_INVESTIGATOR
Department of Molecular Biology, Institute of Basic Medicine, Chinese PLA General Hospital, Beijing, 100853, China.
Lu Shi, Master
Role: PRINCIPAL_INVESTIGATOR
Department of Molecular Biology, Institute of Basic Medicine, Chinese PLA General Hospital, Beijing, 100853, China.
Kaichao Feng, Doctor
Role: PRINCIPAL_INVESTIGATOR
Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
Jingdan Qiu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
Hejin Jia, Doctor
Role: PRINCIPAL_INVESTIGATOR
Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
Locations
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Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Mei Q, Chen M, Lu X, Li X, Duan F, Wang M, Luo G, Han W. An open-label, single-arm, phase I/II study of lower-dose decitabine based therapy in patients with advanced hepatocellular carcinoma. Oncotarget. 2015 Jun 30;6(18):16698-711. doi: 10.18632/oncotarget.3677.
Nie J, Zhang Y, Li X, Chen M, Liu C, Han W. DNA demethylating agent decitabine broadens the peripheral T cell receptor repertoire. Oncotarget. 2016 Jun 21;7(25):37882-37892. doi: 10.18632/oncotarget.9352.
Liu Y, Wang C, Li X, Dong L, Yang Q, Chen M, Shi F, Brock M, Liu M, Mei Q, Liu J, Nie J, Han W. Improved clinical outcome in a randomized phase II study of anti-PD-1 camrelizumab plus decitabine in relapsed/refractory Hodgkin lymphoma. J Immunother Cancer. 2021 Apr;9(4):e002347. doi: 10.1136/jitc-2021-002347.
Wang C, Liu Y, Dong L, Li X, Yang Q, Brock MV, Mei Q, Liu J, Chen M, Shi F, Liu M, Nie J, Han W. Efficacy of Decitabine plus Anti-PD-1 Camrelizumab in Patients with Hodgkin Lymphoma Who Progressed or Relapsed after PD-1 Blockade Monotherapy. Clin Cancer Res. 2021 May 15;27(10):2782-2791. doi: 10.1158/1078-0432.CCR-21-0133. Epub 2021 Mar 5.
Nie J, Wang C, Liu Y, Yang Q, Mei Q, Dong L, Li X, Liu J, Ku W, Zhang Y, Chen M, An X, Shi L, Brock MV, Bai J, Han W. Addition of Low-Dose Decitabine to Anti-PD-1 Antibody Camrelizumab in Relapsed/Refractory Classical Hodgkin Lymphoma. J Clin Oncol. 2019 Jun 10;37(17):1479-1489. doi: 10.1200/JCO.18.02151. Epub 2019 Apr 30.
Other Identifiers
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CHN-PLAGH-BT-019
Identifier Type: -
Identifier Source: org_study_id
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