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HDACi联合ICIs的临床研究（数据来自ClinicalTrials.gov收集截止至2020.6.10）
Clinical study of HDACi combined with ICIs (data collected by ClinicalTrials.gov as of June 10, 2020)
| NCT | Study design | Cancer | Treatment | Outcome measures | Estimated enrollment | Recruitment status |
| MTD: Maximum tolerance dose; DLTs: dose limiting toxicity; iDCR: immune disease control rate; iCR: immune complete response; iSD: immune stable disease; PR: partial response; ORR: objective response rate; BOR: best objective response rate; PFS: progression free survival; DOR: duration of response; CRR: complete response rate; RR: response rate. | ||||||
| 03565406 | Phase Ⅰb | Stage Ⅲ/Ⅳ melanoma | Mocetinostat induction phase+Ipilimumab+Nivolumab | DLTs, MTD | 11 | Terminated |
| 03993626 | Phase Ⅰb/ Ⅱ | Colorectal carcinoma | CXD101+Nivolumab | iDCR, iCR | 55 | Active, not recruiting |
| 02393794 | Phase Ⅰ/Ⅱ | Triple negative breast cancer | Romidepsin+Cisplatin+Nivolumab | Phase Ⅰ：Recommended phase Ⅱ dose of romidepsin in combination with cisplatin Phase Ⅱ：Objective response rate |
54 | Suspended |
| 02453620 | Phase Ⅰ | Breast carcinoma | Entinostat+Ipilimumab+Nivolumab | Incidence of adverse events | 45 | Active, not recruiting |
| 02954991 | Phase Ⅱ | Non-small cell lung cancer | Glesatinib+Nivolumab Sitravatinib+Nivolumab Mocetinostat+Nivolumab |
Number of patients experiencing tumor size reduction | 280 | Active, not recruiting |
| 02935790 | Phase Ⅰ | Malignant melanoma | ACY-241+Ipilimumab+Nivolumab | MTD | 1 | Completed |
| 03838042 | Phase Ⅰ/Ⅱ | Children and adolescents with high-risk refractory malignancies | Nivolumab+Entinostat | StageⅠ：DLTs; StageⅡ：CR, PR | 128 | Recruiting |
| 02635061 | Phase Ⅰ | Non-small cell lung cancer | ACY-241+Nivolumab | Incidence of adverse events, recommended Phase 2 dose | 16 | Active, not recruiting |
| 03552380 | Phase Ⅱ | Renal cell carcinoma | Entinostat+Entinostat+Ipilimumab | QRR, recommended Phase Ⅱ dose | 53 | Active, not recruiting |
| 03250273 | Phase Ⅱ | Cholangiocarcinoma, pancreatic cancer | Entinostat+Nivolumab | QRR | 54 | Active, not recruiting |
| 04315155 | Phase Ⅰ | Metastatic adenocarcinoma | Belinostat+Nivolumab+Ipilimumab | DLTs | 39 | Not yet recruiting |
| 01928576 | Phase Ⅱ | Non-small cell lung cancer | Entinostat+Nivolumab+Azacitidine | OR | 120 | Recruiting |
| 03873025 | Phase Ⅰ/Ⅱ | Diffuse large B-cell lymphoma | CXD101+Pembrolizumab | MTD, BOR | 45 | Not yet recruiting |
| 02437136 | Phase Ⅰ/Ⅱ | Non-small cell lung cancer, melanoma, colorectal cancer | Entinostat+Pembrolizumab | Incidence of adverse events | 202 | Unknown |
| 03426891 | Phase Ⅰ | Glioblastoma | Vorinostat+Pembrolizumab+Temozolomide | MTD | 32 | Recruiting |
| 02909452 | Phase Ⅰ | Solid tumors | Entinostat+Pembrolizumab | Incidence of treatment-emergent adverse events | 30 | Unknown |
| 03765229 | Phase Ⅰ/Ⅱ | Melanoma | Entinostat+Pembrolizumab | Incidence of conversion of non-inflamed to inflamed melanoma | 14 | Recruiting |
| 03978624 | Phase Ⅰ/Ⅱ | Bladder cancer | Entinostat+Pembrolizumab | Change from baseline in Z-score of T cell CD8 immune 37-gene signature | 20 | Recruiting |
| 04357873 | Phase Ⅱ | Squamous cell carcinoma | Vorinostat+Pembrolizumab | ORR | 111 | Recruiting |
| 03179930 | Phase Ⅱ | Lymphomas | Entinostat+Pembrolizumab | Response | 47 | Recruiting |
| 03220477 | Phase Ⅰ | Lung cancer | Mocetinostat+Guadecitabine+Pembrolizumab | RR | 40 | Recruiting |
| 03150329 | Phase Ⅰ | Lymphoma | Vorinostat+Pembrolizumab | Incidence of adverse events | 60 | Recruiting |
| 03590054 | Phase Ⅰ | Melanoma | Abexinostat+Pembrolizumab | MTD, ORR | 40 | Recruiting |
| NCT | Study design | Cancer | Treatment | Outcome Measures | Estimated enrollment | Recruitment status |
| 02619253 | Phase Ⅰ | Renal cell carcinoma, urinary bladder neoplasms | Abexinostat+Pembrolizumab | Recommended phase 2 dose | 57 | Active, not recruiting |
| 02538510 | Phase Ⅰ/Ⅱ | Head and neck squamous cell carcinoma | Vorinostat+Pembrolizumab | Incidence of toxicity graded | 49 | Active, not recruiting |
| 02697630 | Phase Ⅱ | Metastatic uveal melanoma | Entinostat+Pembrolizumab | ORR | 29 | Active, not recruiting |
| 02638090 | Phase Ⅱ | Lung cancer | Vorinostat+Pembrolizumab | MTD | 100 | Recruiting |
| 04190056 | Phase Ⅱ | Breast cancer | Vorinostat+Tamoxifen+Pembrolizumab | ORR | 65 | Not yet recruiting |
| 02395627 | Phase Ⅱ | Breast neoplasms | Vorinostat+Tamoxifen+Pembrolizumab | ORR, treatment-related adverse events | 38 | Active, not recruiting |
| 03820596 | Phase Ⅰ/Ⅱ | Extranodal natural killer/T cell lymphoma | ChidamideSintilimab | Phase Ⅰ: DLTs, MTD, Maximum tolerable dose Phase Ⅱ：PFS, DOR, OS |
50 | Recruiting |
| 02708680 | Phase Ⅰ/Ⅱ | Breast cancer | Entinostat+Atezolizumab | DLTs, MTD, ORR, OS | 88 | Unknown |
| 03024437 | Phase Ⅰ/Ⅱ | Renal cancer | Entinostat+Bevacizumab+Atezolizumab | Recommended phase Ⅱ dose，ORR | 62 | Recruiting |
| 03280563 | Phase Ⅰ/Ⅱ | Breast neoplasms | Entinostat+Atezolizumab+Fulvestrant | ORR | 126 | Recruiting |
| 02805660 | Phase Ⅰ/Ⅱ | Advanced cancer | Mocetinostat+Durvalumab | DLTs | 119 | Active, not recruiting |
| 02915523 | Phase Ⅰ/Ⅱ | Epithelial ovarian cancer, peritoneal cancer, Fallopian tube cancer | Entinostat+Avelumab | Recommended phase 2 dose, PFS, ORR, OS | 140 | Active, not recruiting |
| 02032810 | Phase Ⅰ/Ⅱ | Melanoma, skin cancer | Panobinostat+Ipilimumab | ORR, PFS, OS | 17 | Active, not recruiting |
| 04296942 | Phase Ⅰ | Breast cancer | Entinostat+M7824+BN-Brachyury+T-DM1 | ORR, PFS | 55 | Not yet recruiting |
| 04040491 | Single-arm, Multi-center Clinical study | Peripheral T-cell lymphoma | Chidamide+PD-1 blocking antibody+Lenalidomide+gemcitabine | ORR, PFS, OS | 100 | Recruiting |
| 04038411 | Single-arm, multi-center clinical study | NK/T cell lymphoma | Chidamide+PD-1 blocking antibody+Lenalidomide + Etoposide phosphate | ORR, PFS, OS | 50 | Recruiting |
| 04337606 | Open-label Phase Ⅰ/Ⅱ trial | Non Hodgkin lymphoma | Chidamide+Camrelizumab+Decitabine | CRR, Adverse events | 100 | Recruiting |
| 04512534 | Phase Ⅱ | Peripheral T-cell lymphoma | Chidamide+Sintilimab | PFS, OS | 51 | Recruiting |
| 04025931 | Phase Ⅱ | Sarcoma | Chidamide+Toripalimab | ORR, PFS, OS, DCR | 53 | Recruiting |
| 04414969 | Open-label, multicenter, phase Ⅱ | NK/T cell lymphoma | Chidamide+Anti-PD-1 antibody+Peg-Asparaginase | ORR, PFS, OS, CRR | 35 | Recruiting |