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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-75
SponsorHan weidong

About this 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.

Eligibility criteria

Qualifiers

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.

12 to 75 years of age.

ECOG performance of less than 2.

Life expectancy of at least 3 months.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Anti-PD-1 antibody
  • Decitabine
  • Chemotherapy

Treatment groups

250 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Han weidong

Lead sponsor

Chinese PLA General Hospital

Sponsor institution