Malignant Solid Tumour
Conditions
Keywords
Solid tumor, Anti-PD-1, NK immunotherapy
Brief summary
The aim of this study is the safety and efficacy of anti-PD-1 plus NK immunotherapy to multiple solid tumors.
Detailed description
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).
Interventions
DRUGPembrolizumab
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
BIOLOGICALNK immunotherapy
Each treatment: about 10 billion cells in all, infusion in 3 times, i.v.
Sponsors
Shenzhen Hank Bioengineering Institute
Fuda Cancer Hospital, Guangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 2 year | PFS was defined as the interval between treatment initiation and local relapse, |
| OS | 3 years | OS was calculated as the interval from treatment initiation to death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PD-1 | 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 |
| Tumor size | 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). |
| CEA | 3 months | CEA was evaluated by a chemiluminescent immunoassay before treatment and 90 days after treatment. |
| CTC | 3 months | The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels. |
Countries
China
Outcome results
None listed