study of celecoxib treatment before surgery for patients with uterine cancer

Open label, phase II, Proof of Concept study of neoadjuvant celecoxib in newly diagnosed patients with endometrial carcinoma Acronym: Celebrido - CELEBRIDO

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001071-37-BE

Enrollment

Registered

2019-05-24

Start date

2019-08-06

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with confirmed primary endometrioid adenocarcinoma eligible for first line curative surgery

Interventions

Trade Name: Celecoxib PSUSA/00000616/20 Product Name: Celecoxib Product Code: M01AH01 Pharmaceutical Form: Capsule

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Women > 18 years of age. - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 - Adequate renal, hepatic and haematologic functions as defined by laboratory parameters. - Agrees to undergo additional endometrial biopsies for scientific purposes. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18

Exclusion criteria

Exclusion criteria: - Known hypersensitivity or intolerance to celecoxib - Active, known or suspected autoimmune disease. Vitiligo, type I diabetes mellitus, residual hypothyroidism controlled by hormone substitution therapy, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are allowed. - Positive hepatitis B or C, HIV, and pregnancy tests. - Immunosuppressive treatment

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether neoadjuvant treatment with celecoxib results in reduced tumoural expression of IDO1 and/or increased tumoural T-cell infiltration in patients with endometrial carcinoma;Secondary Objective: To assess the safety and tolerability of treatment with celecoxib;Primary end point(s): Decrease in the proportion of IDO1+ tumour cells by =50%, and increase in the proportion of CD3+ T-cells infiltrating the tumor bed by =50% following celecoxib treatment, as measured by immunostaining and computerized analysis of digitized histological images;Timepoint(s) of evaluation of this end point: the day of the surgery, from 12 to 24 hours after last intake of medication	—

Measure

Time frame

Main Objective: To determine whether neoadjuvant treatment with celecoxib results in reduced tumoural expression of IDO1 and/or increased tumoural T-cell infiltration in patients with endometrial carcinoma;Secondary Objective: To assess the safety and tolerability of treatment with celecoxib;Primary end point(s): Decrease in the proportion of IDO1+ tumour cells by =50%, and increase in the proportion of CD3+ T-cells infiltrating the tumor bed by =50% following celecoxib treatment, as measured by immunostaining and computerized analysis of digitized histological images;Timepoint(s) of evaluation of this end point: the day of the surgery, from 12 to 24 hours after last intake of medication

—

Secondary

Measure	Time frame
Secondary end point(s): Assessment and scaling of adverse events according to CTC-NCIv4.03, and of surgical safety according to the Dindo-Clavien scale for evaluation of post-operative complications;Timepoint(s) of evaluation of this end point: from the first intake of medication to 24 hours afeter surgey	—

Countries

Belgium

Contacts

Public Contactguichet académique CTC Leva

Cliniques Universitaires Saint-Luc

guichetacademique-saintluc@uclouvain.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026