A Prospective Study of Monitoring Immune Response in Locally Advanced Cervix Cancer

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sichuan University
• Treatments: Cisplatin

Criteria

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