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

Sichuan University

Status: Unknown

Conditions: Cervical Cancer

Treatments: Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03559803

GHR-002

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

5. 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

Cisplatin

Experimental group

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.

Treatment:

Drug: Cisplatin