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| Name | Class |
|---|---|
| Shenzhen Hank Bioengineering Institute | OTHER |
The aim of this study is the safety and efficacy of anti-PD-1 plus NK immunotherapy to multiple solid tumors.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab and NK immunotherapy | Experimental | In this group, the patients will receive regular Pembrolizumab first to control tumor burden; then NK immunotherapy will be given. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
|
| Pembrolizumab | Active Comparator | In this group, the patients will receive regular Pembrolizumab to control tumor burden. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | PFS was defined as the interval between treatment initiation and local relapse, | 2 year |
| OS | OS was calculated as the interval from treatment initiation to death. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| PD-1 | Peripheral blood (6 mL) was obtained from healthy donors and patients before treatment and 90 days after treatment for the detection of PD-1 | 3 months |
| Tumor size | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jibing Chen, MD, PhD | Fuda Cancer Hospital, Guangzhou | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute in Fuda Cancer Hospital | Guangzhou | Guangdong | 510665 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32027620 | Derived | Lin M, Luo H, Liang S, Chen J, Liu A, Niu L, Jiang Y. Pembrolizumab plus allogeneic NK cells in advanced non-small cell lung cancer patients. J Clin Invest. 2020 May 1;130(5):2560-2569. doi: 10.1172/JCI132712. |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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| NK immunotherapy | Biological | Each treatment: about 10 billion cells in all, infusion in 3 times, i.v. |
|
| 3 months |
| CEA | CEA was evaluated by a chemiluminescent immunoassay before treatment and 90 days after treatment. | 3 months |
| CTC | The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels. | 3 months |