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Perspectives:
To analyse if the change of specific immune response will correlate with clinical effect of advanced cervix cancer after radio-chemotherapy.
To evaluate the specific immune response throughout monitor the change of the programmed death-1(PD-1) in CD8 T cell and CD4 T cell and Treg cell in blood at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.
To use immunohistochemistry (IHC) technique to monitor the change of programmed death-ligand 1 (PD-L1),CD68,CD8,CD4,PD1 and Treg expression in biopsy at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.
To detect the change of T cell receptor(TCR) repertoire and Tumor mutation burden (TMB) at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.
Cervical cancer is the fourth most common cancer among women worldwide. At present, patients with cervical cancer are treated with radical hysterectomy and pelvic lymphadenectomy or chemoradiation. To improve the prognosis of cervical cancer patients, novel immunotherapeutic strategies need to be developed. Now there are some clinical phase I/II trials ongoing to assess the effects of ipilimumab, pembrolizumab and nivolumab in advanced cervical cancer,but information on the clinical significance of PD-L1 expression in cervical cancer is largely lacking.In this study, the investigator's primary objective:
To analyse if the change of specific immune response will correlate with clinical effect of advanced cervix cancer after radio-chemotherapy.
To evaluate the specific immune response throughout monitor the change of PD-1 in CD8 T cell and CD4 T cell and Treg cell in blood at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.
To use IHC technique to monitor the change of PD-L1, CD68,CD8,CD4,PD1 and Treg expression in biopsy at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.
To detect the change of TCR repertoire and TMB at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cisplatin | Experimental | Weekly cisplatin (40 mg/m²) will be administered during radiotherapy. At least 3 cycles of cisplatin should be performed according to the hematological and renal functions but not mandatory. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | Drug: Cisplatin injection Weekly cisplatin (40 mg/m²) will be administered during radiotherapy. At least 3 cycles of cisplatin should be performed according to the hematological and renal functions but not mandatory. Combination Product: radiotherapy A total dose of 45Gy in 25 fractions to the PTV is considered standard but simultaneous integrated boost or two steps boost to specific volumes (positive lymph nodes for example) are accepted and left to the investigator's discretion). |
| Measure | Description | Time Frame |
|---|---|---|
| The change of expression of PD-L1+ on cervix biopsies | The biopsy was collected at baseline,3 weeks,2 months | From baseline,3 weeks,2 months |
| Measure | Description | Time Frame |
|---|---|---|
| The change of expression of PD1 on the non-regulatory CD4+ and CD8+ lymphocytes and Treg cells | The blood was collected at baseline,3 weeks,2 months | baseline,3 weeks,2 months |
| The diversity of T-cell Repertoire in cervix biopsies and blood, respectively |
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Inclusion Criteria:
4. Patients must be affiliated to a Social Security System. 6. Patient information and written informed consent form signed.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| You Lu, MD | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guizhou Province People's Hospital | Guizhou | Guizhou | China | |||
| West China Hospital, Sichuan University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19901438 | Background | Jayshree RS, Sreenivas A, Tessy M, Krishna S. Cell intrinsic & extrinsic factors in cervical carcinogenesis. Indian J Med Res. 2009 Sep;130(3):286-95. | |
| 19931186 | Background | Folkl A, Bienzle D. Structure and function of programmed death (PD) molecules. Vet Immunol Immunopathol. 2010 Mar 15;134(1-2):33-8. doi: 10.1016/j.vetimm.2009.10.006. Epub 2009 Oct 14. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 25, 2021 | |
| Reset | Apr 21, 2021 | |
| Release | Dec 2, 2021 | |
| Reset | Feb 17, 2022 | |
| Release | Jun 19, 2022 | |
| Reset | Mar 30, 2023 | |
| Release | May 10, 2023 | |
| Reset | Jan 24, 2024 | |
| Release | Mar 19, 2024 | |
| Reset | Aug 14, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 25, 2021 | Apr 21, 2021 | |||
| Dec 2, 2021 |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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|
|
The blood and biopsies were collected at baseline,3 weeks,2 months |
| baseline,3 weeks,2 months |
| The change of expression of CD8+PD1+ lymphocytes infiltrate on cervix biopsies | The biopsy was collected at baseline,3 weeks,2 months | baseline,3 weeks,2 months |
| Chengdu |
| Sichuan |
| 610041 |
| China |
| 19188168 | Background | Gao Q, Wang XY, Qiu SJ, Yamato I, Sho M, Nakajima Y, Zhou J, Li BZ, Shi YH, Xiao YS, Xu Y, Fan J. Overexpression of PD-L1 significantly associates with tumor aggressiveness and postoperative recurrence in human hepatocellular carcinoma. Clin Cancer Res. 2009 Feb 1;15(3):971-9. doi: 10.1158/1078-0432.CCR-08-1608. |
| 24548766 | Background | Yang CY, Lin MW, Chang YL, Wu CT, Yang PC. Programmed cell death-ligand 1 expression in surgically resected stage I pulmonary adenocarcinoma and its correlation with driver mutations and clinical outcomes. Eur J Cancer. 2014 May;50(7):1361-9. doi: 10.1016/j.ejca.2014.01.018. Epub 2014 Feb 15. |
| 25477049 | Background | Madore J, Vilain RE, Menzies AM, Kakavand H, Wilmott JS, Hyman J, Yearley JH, Kefford RF, Thompson JF, Long GV, Hersey P, Scolyer RA. PD-L1 expression in melanoma shows marked heterogeneity within and between patients: implications for anti-PD-1/PD-L1 clinical trials. Pigment Cell Melanoma Res. 2015 May;28(3):245-53. doi: 10.1111/pcmr.12340. Epub 2014 Dec 22. |
| 24842267 | Background | Muenst S, Schaerli AR, Gao F, Daster S, Trella E, Droeser RA, Muraro MG, Zajac P, Zanetti R, Gillanders WE, Weber WP, Soysal SD. Expression of programmed death ligand 1 (PD-L1) is associated with poor prognosis in human breast cancer. Breast Cancer Res Treat. 2014 Jul;146(1):15-24. doi: 10.1007/s10549-014-2988-5. Epub 2014 May 20. |
| 20473887 | Background | Shi F, Shi M, Zeng Z, Qi RZ, Liu ZW, Zhang JY, Yang YP, Tien P, Wang FS. PD-1 and PD-L1 upregulation promotes CD8(+) T-cell apoptosis and postoperative recurrence in hepatocellular carcinoma patients. Int J Cancer. 2011 Feb 15;128(4):887-96. doi: 10.1002/ijc.25397. |
| 27056074 | Background | Heeren AM, Punt S, Bleeker MC, Gaarenstroom KN, van der Velden J, Kenter GG, de Gruijl TD, Jordanova ES. Prognostic effect of different PD-L1 expression patterns in squamous cell carcinoma and adenocarcinoma of the cervix. Mod Pathol. 2016 Jul;29(7):753-63. doi: 10.1038/modpathol.2016.64. Epub 2016 Apr 8. |
| 26623522 | Background | Lim SH, Hong M, Ahn S, Choi YL, Kim KM, Oh D, Ahn YC, Jung SH, Ahn MJ, Park K, Zo JI, Shim YM, Sun JM. Changes in tumour expression of programmed death-ligand 1 after neoadjuvant concurrent chemoradiotherapy in patients with squamous oesophageal cancer. Eur J Cancer. 2016 Jan;52:1-9. doi: 10.1016/j.ejca.2015.09.019. Epub 2015 Nov 26. |
| 25702326 | Background | Zhang J, Fang W, Qin T, Yang Y, Hong S, Liang W, Ma Y, Zhao H, Huang Y, Xue C, Huang P, Hu Z, Zhao Y, Zhang L. Co-expression of PD-1 and PD-L1 predicts poor outcome in nasopharyngeal carcinoma. Med Oncol. 2015 Mar;32(3):86. doi: 10.1007/s12032-015-0501-6. Epub 2015 Feb 22. |
| Feb 17, 2022 |
| Jun 19, 2022 | Mar 30, 2023 |
| May 10, 2023 | Jan 24, 2024 |
| Mar 19, 2024 | Aug 14, 2024 |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D013812 |
| Therapeutics |