Clinical trial · Interventional
A Prospective Study of Monitoring Immune Response in Locally Advanced Cervix Cancer
A Prospective Study of Dynamic Monitoring Specific Immune Response in Locally Advanced Cervix Cancer After Radio-chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cisplatin
- description
- 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.
- interventionNames
- Drug: Cisplatin
Primary outcomes (1)
- measure
- The change of expression of PD-L1+ on cervix biopsies
- timeFrame
- From baseline,3 weeks,2 months
- description
- The biopsy was collected at baseline,3 weeks,2 months
Secondary outcomes (3)
- measure
- The change of expression of PD1 on the non-regulatory CD4+ and CD8+ lymphocytes and Treg cells
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age:18-70 years. 2. All FIGO stages cervical cancers which are the matter for radiochemotherapy and exclusive brachytherapy indications. 3. ECOG:0-1. 4. Ability to give informed consent. 4\. Patients must be affiliated to a Social Security System. 6. Patient information and written informed consent form signed. Exclusion Criteria: 1. Known autoimmune disorder. 2. History of HIV and/ or active hepatitis infection. 3. History of pelvic radiation or radio-chemotherapy. 4. Recurrent or metastatic cervical cancer. 5. Contra-indication for cisplatin. 6. Patient pregnant and/or breastfeeding. 7. Patients with psychological or familial disease potentially hampering compliance with the study protocol and follow-up schedule
References
Publications (10)
- BACKGROUNDJayshree RS, Sreenivas A, Tessy M, Krishna S. Cell intrinsic & extrinsic factors in cervical carcinogenesis. Indian J Med Res. 2009 Sep;130(3):286-95. PMID 19901438
- BACKGROUNDFolkl 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. PMID 19931186
- BACKGROUNDGao 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. PMID 19188168
- BACKGROUNDYang 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. PMID 24548766
- BACKGROUNDMadore 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. PMID 25477049
- BACKGROUNDMuenst 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. PMID 24842267
- BACKGROUNDShi 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.