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Completed

NCT Number: NCT02843204

Combination of Anti-PD-1 and NK Immunotherapy for Recurrent Solid Tumors

The aim of this study is the safety and efficacy of anti-PD-1 plus NK immunotherapy to multiple solid tumors.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cancer Institute in Fuda Cancer Hospital

Guangzhou, Guangdong, 510665, China

About this study

By enrolling patients with solid tumors adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using anti-PD-1 and natural killer (NK) cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
  • Progression after chemotherapy or appropriate TKI treatment for those patients with an EGFR-sensitizing mutation or ALK rearrangement
  • KPS ≥ 70, lifespan > 3 months, PD-L1 TPS of 1% or greater
  • Platelet count ≥ 80×10^9/L,white blood cell count ≥ 3×10^9/L, neutrophil count ≥ 2×10^9/L, hemoglobin ≥ 80 g/L

Exclusion criteria

  • Patients with cardiac pacemaker
  • Patients with brain metastasis
  • Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction, myelosuppression, autoimmune disease, pneumonitis
  • Previous treatment with a therapeutic antibody against CTLA4, PD-L1, or PD-1, or PD-L1/PD-1 pathway-targeting agents.

Treatment and study plan

Pembrolizumab

Drug

Patients received i.v. pembrolizumab (10 mg/kg) on day 1 of a 21-day cycle, until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure

Other names: Keytruda

NK immunotherapy

Biological

Each treatment: about 10 billion cells in all, infusion in 3 times, i.v.

Primary outcomes

  1. PFS

    Time frame: 2 year

    PFS was defined as the interval between treatment initiation and local relapse,

  2. OS

    Time frame: 3 years

    OS was calculated as the interval from treatment initiation to death.

Secondary outcomes

  1. PD-1

    Time frame: 3 months

    Peripheral blood (6 mL) was obtained from healthy donors and patients before treatment and 90 days after treatment for the detection of PD-1

  2. Tumor size

    Time frame: 3 months

    The tumor responses of the enrolled patients were assessed by CT in accordance with RECIST v1.1.Institute Common Terminology Criteria for Adverse Events (v4.0).

  3. CEA

    Time frame: 3 months

    CEA was evaluated by a chemiluminescent immunoassay before treatment and 90 days after treatment.

  4. CTC

    Time frame: 3 months

    The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels.

Sponsors and collaborators

Lead sponsor

Fuda Cancer Hospital, Guangzhou

Other

Collaborators

  • Shenzhen Hank Bioengineering Institute

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Jul 25, 2016
Registry last updated
May 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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