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Targeting inflammation to reduce 90-day and 1-year postoperative severe morbidity in patients with unfavorable inflammatory profile undergoing oncologic surgery (POST CARE Trial)
EU CTIS ID: 2024-515333-14-03
What this study is testing
The primary objective of this study is to: -test the clinical efficacy of the experimental treatment -test the safety of the experimental treatment
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Adequate organ function: absolute neutrophil count ≥ 1,500/mm^3 platelet count ≥ 100,000/mm^3 hemoglobin ≥ 9 g/dl AST and ALT ≤ 1.5* times upper limit of normal (ULN) bilirubin ≤ 1.5* times ULN creatinine clearance ≥ 45 ml/min or serum creatinine ≤1.5 x ULN NOTE: * ≤ 3 times ULN if liver metastases are present
- Ability of subject to understand and the willingness to sign a written informed consent document
- Previous aspirin therapy is not an exclusion criteria
- Histologically documented cancer
- Surgery performed for curative intent
You likely can't join if
- Patients undergoing palliative surgery
- Allogeneic tissue/solid organ transplant
- Autologous/allogeneic stem cell transplantation
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Known hypersensitivity to active substances (ketorolac and aspirin) or any of their excipients including previous clinically significant hypersensitivity reaction to treatments.
- Medical contraindication to non-steroidal anti-inflammatory drugs / aspirin administration
See the full eligibility criteria
Who can join
- Age ≥ 18 years
- Adequate organ function: absolute neutrophil count ≥ 1,500/mm^3 platelet count ≥ 100,000/mm^3 hemoglobin ≥ 9 g/dl AST and ALT ≤ 1.5* times upper limit of normal (ULN) bilirubin ≤ 1.5* times ULN creatinine clearance ≥ 45 ml/min or serum creatinine ≤1.5 x ULN NOTE: * ≤ 3 times ULN if liver metastases are present
- Ability of subject to understand and the willingness to sign a written informed consent document
- Previous aspirin therapy is not an exclusion criteria
- Histologically documented cancer
- Surgery performed for curative intent
- High RBT index (≥18)
- Patients scheduled for major surgical procedures (including thoracic, head and neck, abdominal (peritoneal/retroperitoneal), urogenital, and breast/reconstructive surgeries
- Major surgery is defined according to the extent and complexity of the procedure, its pathophysiological consequences and consecutive clinical outcomes, according to the criteria proposed by Marin et al. in 2020
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Female participants must not be pregnant, not breastfeeding. Women of childbearing age must agree to use study-approved contraception during the treatment period and for at least 120 days after the last dose of study treatment
- Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mmHg at screening and no change in antihypertensive medications
What rules you out
- Patients undergoing palliative surgery
- Allogeneic tissue/solid organ transplant
- Autologous/allogeneic stem cell transplantation
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Known hypersensitivity to active substances (ketorolac and aspirin) or any of their excipients including previous clinically significant hypersensitivity reaction to treatments.
- Medical contraindication to non-steroidal anti-inflammatory drugs / aspirin administration
- Known history of human immunodeficiency virus (HIV) infection and/or HIV-related Kaposi Sarcoma
- Known history of or positivity for hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- History of (non-infectious) pneumonitis that required steroids or current pneumonitis; history of active tuberculosis (Bacillus tuberculosis)
- Clinically significant cardiovascular disease within 12 months of the first dose of study treatment including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
- Prior therapy with a monoclonal antibody, chemotherapy, or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer) before administration of study treatment
- Patients undergoing neuro-surgical procedures
- Vaccination with live vaccine(s) within 30 days before the first dose of study treatment
- Patients with specific or nutritional dietary requirement (malnutrition or at high risk for malnutrition, sarcopenic or high risk to be sarcopenic)
- Low body mass index (BMI<18.5kg/m2)
- Have type 1 diabetes mellitus or type 2 diabetes mellitus treated with insulin or insulin secretagogues
- Any post-surgical nutritional requirements (e.g., patients deserving to have parenteral nutrition after discharge will be excluded from the trial)
- Any patient with a known predisposing history of a coagulation or platelet defect
- Any autoimmune, connective tissue or inflammatory disorders (e.g., rheumatoid arthritis, Sjogren’s, sarcoidosis etc.) detected at the time of screening.
- Diagnosis of immunodeficiency or chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.