Health TrialsbyHealthPanel

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

ConditionMalignancies Multiple
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Anti-PD-1 antibody

    Drug

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

  • Decitabine

    Drug

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

  • Chemotherapy

    Drug

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

Treatment groups

250 Participants
are divided into 3 treatment groups
Group A: Anti-PD-1 antibody+decitabineExperimental treatment 2 interventions
Group B: Anti-PD-1 antibodyExperimental treatment 1 intervention
Group C: Anti-PD-1 antibody+chemotherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
2 years

Secondary outcomes

1

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

Time frame
3 years
2

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

Time frame
3 years
3

Progression free survival

Time frame
5 years
4

Overall survival

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Han weidong

Lead sponsor

Chinese PLA General Hospital

Sponsor institution

Source ClinicalTrials.gov
Apply now