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| Name | Class |
|---|---|
| Hangzhou Neoantigen Therapeutics Co., Ltd. | INDUSTRY |
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This research study is evaluating a new type of personalized neoantigen cancer vaccine(iNeo-Vac-P01)combined with anti-PD-1 antibody and radiofrequency ablation as a possible treatment for patients with advanced solid tumors. The primary objective of this trial is to evaluate safety, tolerability and immunogenicity of iNeo-Vac-P01 in combination with anti-PD-1 and radiofrequency ablation, so as to provide a new personalized therapeutic strategy for patients.
It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RFA+PD-1+iNeo-Vac-P01 | Experimental | Patients will undergo radiofrequency ablation. At Week 3, patients will receive PD-1 at a dose of 200mg administered by intravenous infusion (IV) every 2 weeks. At Week 12,all patients,regardless of their disease status,iNeo-Vac-P01(300mcg per peptide)+ GM-CSF (40mcg) on days 1, 4, 8, 15, 22, 52, and 82 from week 12. Additional booster vaccines might be administered depending on ethics and patients' potential benefit. |
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| RFA+iNeo-Vac-P01+PD-1 | Experimental | Patients will undergo radiofrequency ablation. At Week 12, patients will receive iNeo-Vac-P01(300mcg per peptide)+ GM-CSF (40mcg) on days 1, 4, 8, 15, 22, 52, and 82 from week 12. Additional booster vaccines might be administered depending on ethics and patients' potential benefit. At Week 16, patients,regard of their disease status,will receive PD-1 at a dose of 200mg administered by intravenous infusion (IV) every 2 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iNeo-Vac-P01 | Biological | iNeo-Vac-P01: 300 mcg per peptide |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing clinical and laboratory adverse events (AEs) | Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0. | 1 year |
| Objective Response Rate | ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. | 5 years |
| Measurement of CD4/CD8 T lymphocyte subsets. | CD4/CD8 T lymphocyte subsets were detected by flow cytometry. | 3 years |
| The IFN-γ T cells responses induced by neoantigen | The response of IFN-γ T cells induced by neoantigen was detected by ELispot. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival(OS) | Time from surgery to death or last follow-up. | 5 years |
| Progression-free Survival(PFS) | Time from surgery to any progression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Yong, MD, PhD | Contact | +86-571-87887821 | 307480770@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32439700 | Background | Fang Y, Mo F, Shou J, Wang H, Luo K, Zhang S, Han N, Li H, Ye S, Zhou Z, Chen R, Chen L, Liu L, Wang H, Pan H, Chen S. A Pan-cancer Clinical Study of Personalized Neoantigen Vaccine Monotherapy in Treating Patients with Various Types of Advanced Solid Tumors. Clin Cancer Res. 2020 Sep 1;26(17):4511-4520. doi: 10.1158/1078-0432.CCR-19-2881. Epub 2020 May 21. | |
| 33064988 |
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| ID | Term |
|---|---|
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| D000276 | Adjuvants, Immunologic |
| D003115 | Colony-Stimulating Factors |
| D000082082 | Immune Checkpoint Inhibitors |
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
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| GM-CSF | Other | GM-CSF: 40 mcg |
|
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| PD-1 | Drug | PD-1: 200mg administered by intravenous infusion every 2 weeks. |
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| RFA | Procedure | Radiofrequency ablation surgery |
|
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| 3 years |
| Peripheral blood T cell receptor sequencing analysis | The diversity and clonability of T cells were analyzed by peripheral blood T cell receptor sequencing. | 2 years |
| Ott PA, Hu-Lieskovan S, Chmielowski B, Govindan R, Naing A, Bhardwaj N, Margolin K, Awad MM, Hellmann MD, Lin JJ, Friedlander T, Bushway ME, Balogh KN, Sciuto TE, Kohler V, Turnbull SJ, Besada R, Curran RR, Trapp B, Scherer J, Poran A, Harjanto D, Barthelme D, Ting YS, Dong JZ, Ware Y, Huang Y, Huang Z, Wanamaker A, Cleary LD, Moles MA, Manson K, Greshock J, Khondker ZS, Fritsch E, Rooney MS, DeMario M, Gaynor RB, Srinivasan L. A Phase Ib Trial of Personalized Neoantigen Therapy Plus Anti-PD-1 in Patients with Advanced Melanoma, Non-small Cell Lung Cancer, or Bladder Cancer. Cell. 2020 Oct 15;183(2):347-362.e24. doi: 10.1016/j.cell.2020.08.053. |
| D016207 |
| Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |