CI

At a glance

ClinicalIndex Comparison Record
N/AUnknown· 58 enrolled
Drug / intervention
Cisplatindrug
Likely dose
Cisplatin 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03559803
NCT03559803N/AUnknown

A Prospective Study of Dynamic Monitoring Specific Immune Response in Locally Advanced Cervix Cancer After Radio-chemotherapy

Sichuan University·interventional·Posted Jun 18, 2018·Updated Jan 22, 2019

In Brief

A clinical study evaluating Cisplatin for Cervical Cancer. Targeting 58 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer
CountriesChina
Collaborators--

Timeline

N/AUnknownOverdue
2017201820192020202120222023202420252026
First PostedJun 18, 2018
Enrollment StartOct 1, 2016
Primary CompletionDec 1, 2019
TodayJul 1, 2026
Enrollment to primary: 3.2 yearsPosted 8.0 years ago

Interventions

Cisplatindrug

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).