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Trial record 3 of 43 for:    Han weidong

Anti-PD-1 Antibody Alone or in Combination With Decitabine/Chemotherapy in Relapsed or Refractory Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02961101
Recruitment Status : Recruiting
First Posted : November 10, 2016
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Han weidong, Chinese PLA General Hospital

Tracking Information
First Submitted Date  ICMJE November 2, 2016
First Posted Date  ICMJE November 10, 2016
Last Update Posted Date July 9, 2019
Study Start Date  ICMJE May 2016
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2016)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2016)
  • 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: 3 years ]
  • Overall survival [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anti-PD-1 Antibody Alone or in Combination With Decitabine/Chemotherapy in Relapsed or Refractory Malignancies
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malignancies Multiple
Intervention  ICMJE
  • Drug: Anti-PD-1 antibody
    Anti-PD-1 antibody will be given at 1-3mg/kg on day8 by IV every three weeks
  • Drug: Decitabine
    Decitabine will be given at 10mg/d on day 1to 5 by IV every three weeks
  • Drug: Chemotherapy
    Chemotherapy be given depends on the cancer type and treatment regimen before enrollment.
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Drug: Anti-PD-1 antibody
    • Drug: Decitabine
  • Experimental: Anti-PD-1 antibody
    Anti-PD-1 antibody 200mg IV Q3 weeks until progression.
    Intervention: Drug: Anti-PD-1 antibody
  • Experimental: 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.
    Interventions:
    • Drug: Anti-PD-1 antibody
    • Drug: Chemotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 28, 2018)
250
Original Estimated Enrollment  ICMJE
 (submitted: November 8, 2016)
100
Estimated Study Completion Date  ICMJE May 2020
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects must have histological confirmation of 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.
  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:

  1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Weidong Han, doctor +86-010-66937463 hanwdrsw@sina.com
Contact: Qingming Yang, doctor +86-010-55499341 yangqm@medmail.com.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02961101
Other Study ID Numbers  ICMJE CHN-PLAGH-BT-019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Han weidong, Chinese PLA General Hospital
Study Sponsor  ICMJE Han weidong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Chunmeng Wang, Master Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
Study Director: Wenying Zhang, Master Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
Study Director: Yang Liu, Doctor Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
Study Director: Meixia Chen, Doctor Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
Principal Investigator: Yan Zhang, Doctor Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
Study Director: Qian Mei, Doctor Department of Molecular Biology, Institute of Basic Medicine, Chinese PLA General Hospital, Beijing, 100853, China.
Study Director: Jing Nie, Doctor Department of Molecular Biology, Institute of Basic Medicine, Chinese PLA General Hospital, Beijing, 100853, China.
Principal Investigator: Xiang Li, Master Department of Molecular Biology, Institute of Basic Medicine, Chinese PLA General Hospital, Beijing, 100853, China.
Principal Investigator: Liang Dong, Master Department of Molecular Biology, Institute of Basic Medicine, Chinese PLA General Hospital, Beijing, 100853, China.
Principal Investigator: Lu Shi, Master Department of Molecular Biology, Institute of Basic Medicine, Chinese PLA General Hospital, Beijing, 100853, China.
Principal Investigator: Kaichao Feng, Doctor Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
Principal Investigator: Jingdan Qiu, Doctor Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
Principal Investigator: Hejin Jia, Doctor Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
PRS Account Chinese PLA General Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP