ClinicaliQ Trial Snapshot
- NEOadjuvant PembRolizumab In Stratified Medicine – ColoRectal Cancer — Recruiting • Phase II • Oncology • NCT05197322.
- What is being tested: Neoadjuvant pembrolizumab (an anti-PD-1 immunotherapy) combined with standard chemotherapy and/or radiotherapy in stratified cohorts of early-stage colorectal cancer patients, assessed through a precision medicine approach based on tumour molecular characteristics.
- Patient eligibility overview: Early-stage colorectal cancer patients suitable for surgical resection, stratified by tumour biomarkers (such as microsatellite instability and mismatch repair status) to identify those most likely to benefit from immunotherapy intensification.
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What This Trial Is Studying
Colorectal cancer (CRC) is the 2nd to 3rd most common malignant disease in developed countries, with over 1 million new cases and 500,000 deaths worldwide each year. The primary treatment for early stage CRC is surgery to remove the tumour, which is possible in 80% of patients. Even after surgery up to half of patients will develop recurrence or spread of the disease (metastases) which is incurable. Survival after 5 years is approximately 14% for patients with metastatic disease. Clinical trials using immunotherapy drugs called 'immune checkpoint inhibitors' have shown…
Eligibility Snapshot
- : 1. Histologically proven adenocarcinoma of the colon or rectum which is MMR-d by IHC or MSI-H by PCR (or microsatellite testing if routine practice).
- Patient is fit (ECOG 0-1) and eligible for planned curative surgery in keeping with NICE guidelines and considered fit/suitable for adjuvant chemotherapy as per local site investigator's discretion based on: 1. Radiological node positive T1-4 CRC or 2. Node negative high risk T3 defined as EITHER ≥ 5mm of extramural depth of invasion OR unequivocal EMVI on imaging (regardless of depth) or Node negative T4 disease 3. Patients with rectal cancer are eligible if it is determined that neoadjuvant chemo-radiotherapy is not required to achieve a R0 resection. 4. Patients presenting with acute colonic obstruction may enter the trial only after obstruction is relieved by a successful defunctioning stoma/stent, and when recovered to a fitness level consistent with the other eligibility criteria 5. Adequate bone marrow function: * White Blood Cell >3.0 x 10^9/L; * Absolute neutrophil count ≥1.5 x 10^9/L * Platelets ≥100 x 10^9/L. * Haemoglobin ≥90 g/L 6. Adequate renal function: GFR >50 mL/min estimated using validated creatinine clearance calculation (e.g. Cockroft-Gault) NB If the calculated creatinine clearance is <…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.