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

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.

Conditions

• Malignancies Multiple

Interventions

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.

Sponsors & Collaborators

• Han weidong

  lead OTHER

Principal Investigators

• Chunmeng Wang, Master · Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853

• Wenying Zhang, Master · Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853

• Yang Liu, Doctor · Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853

• Meixia Chen, Doctor · Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853

• Yan Zhang, Doctor · Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853

• Qian Mei, Doctor · Department of Molecular Biology, Institute of Basic Medicine, Chinese PLA General Hospital, Beijing, 100853, China.

• Jing Nie, Doctor · Department of Molecular Biology, Institute of Basic Medicine, Chinese PLA General Hospital, Beijing, 100853, China.

• Xiang Li, Master · Department of Molecular Biology, Institute of Basic Medicine, Chinese PLA General Hospital, Beijing, 100853, China.

• Liang Dong, Master · Department of Molecular Biology, Institute of Basic Medicine, Chinese PLA General Hospital, Beijing, 100853, China.

• Lu Shi, Master · Department of Molecular Biology, Institute of Basic Medicine, Chinese PLA General Hospital, Beijing, 100853, China.

• Kaichao Feng, Doctor · Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853

• Jingdan Qiu, Doctor · Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853

• Hejin Jia, Doctor · Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-05-31

Primary Completion

2026-05-31

Completion

2026-05-31

Countries

• China

Study Locations