NCT02961101

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2016

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 10, 2016

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

10 years

First QC Date

November 2, 2016

Last Update Submit

January 21, 2026

Conditions

Malignancies Multiple

Keywords

relapsed or refractorymalignanciesdecitabineanti-PD-1 antibodychemotherapy

Outcome Measures

Primary Outcomes (1)

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

    2 years

Secondary Outcomes (4)

  • Objective response by Response Evaluation Criteria in Solid Tumors (RECIST1.1).

    3 years

  • Objective response by the International Workshop to Standardize Response Criteria for lymphomas.

    3 years

  • Progression free survival

    5 years

  • Overall survival

    5 years

Study Arms (3)

Anti-PD-1 antibody+decitabine

EXPERIMENTAL

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 antibodyDrug: Decitabine

Anti-PD-1 antibody

EXPERIMENTAL

Anti-PD-1 antibody 200mg IV Q3 weeks until progression.

Drug: Anti-PD-1 antibody

Anti-PD-1 antibody+chemotherapy

EXPERIMENTAL

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 antibodyDrug: Chemotherapy

Interventions

Anti-PD-1 antibodyDRUG

Anti-PD-1 antibody will be given at 1-3mg/kg on day8 by IV every three weeks

Anti-PD-1 antibodyAnti-PD-1 antibody+chemotherapyAnti-PD-1 antibody+decitabine
DecitabineDRUG

Decitabine will be given at 10mg/d on day 1to 5 by IV every three weeks

Anti-PD-1 antibody+decitabine
ChemotherapyDRUG

Chemotherapy be given depends on the cancer type and treatment regimen before enrollment.

Anti-PD-1 antibody+chemotherapy

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • to 75 years of age.
  • ECOG performance of less than 2.
  • Life expectancy of at least 3 months.
  • 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.
  • 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.
  • Subjects must have adequate bone marrow, live, renal, lung and heart functions.
  • Absolute neutrophil count greater than or equal to 1,000/μL.
  • Platelet count greater than or equal to 70,000/µL.
  • Serum bilirubin level less than or equal to 1.5 x upper limits of normal (ULN).
  • Serum creatinine less than or equal to 1.5 x ULN.
  • Alanine aminotransferase \[ALT or SGPT\] and aspartate aminotransferase \[AST or SGOT\] less than or equal to 2.5 x ULN.

You may not qualify if:

  • Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
  • Serious uncontrolled medical disorders or active infections, pulmonary and intestinal infection especially.
  • Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .
  • Prior organ allograft.
  • Women who are pregnant or breastfeeding.
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biotherapeutic Department of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 25895027RESULT

  • 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.

    PMID: 27191266RESULT

  • 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.

    PMID: 33820822DERIVED

  • 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.

    PMID: 33674274DERIVED

  • 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.

    PMID: 31039052DERIVED

MeSH Terms

Conditions

RecurrenceNeoplasms

Interventions

spartalizumabDecitabineDrug Therapy

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesTherapeutics

Study Officials

  • 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

    STUDY DIRECTOR

  • Yan Zhang, Doctor

    Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853

    PRINCIPAL INVESTIGATOR

  • 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.

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weidong Han, doctor

CONTACT

+86-010-66937463hanwdrsw@sina.com

Qingming Yang, doctor

CONTACT

+86-010-55499341yangqm@medmail.com.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 10, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

January 22, 2026

Record last verified: 2026-01

Locations

CN(1)