PCSK9 Inhibitor and PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy for pMMR/MSS Local… (NCT06933251) | Clinical Trial Compass
Active — Not RecruitingPhase 2
PCSK9 Inhibitor and PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy for pMMR/MSS Locally Advanced Rectal Cancer
China30 participantsStarted 2025-01-20
Plain-language summary
This is a single-center, open-label, single-arm clinical study aimed at conducting a preliminary evaluation of the efficacy and safety of combining PCSK9 inhibitors and PD-1 inhibitors (dual inhibitors) with neoadjuvant chemoradiotherapy in patients with pMMR/MSS locally advanced rectal cancer.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age between 18 and 75 years, regardless of gender;
✓. Histologically confirmed pMMR/MSS rectal adenocarcinoma, with clinical staging of cT3/T4 or cN+, and tumor located ≤12 cm from the anal verge;
✓. No distant metastasis;
✓. ECOG performance status of 0-1;
✓. Baseline hematological and biochemical parameters meet the following criteria: neutrophils ≥1.5×10\^9/L, hemoglobin ≥90 g/L, platelets ≥100×10\^9/L, ALT/AST ≤2.5 ULN, creatinine ≤1 ULN;
✓. Good compliance and willingness to sign an informed consent form.
Exclusion criteria
✕. History of allergies to PCSK9 monoclonal antibody, PD-1 monoclonal antibody, capecitabine, or oxaliplatin;
✕. Preoperative pathological diagnosis of non-pMMR/MSS rectal adenocarcinoma;
✕. Use of other long-term lipid-lowering drugs leading to conditions such as hypolipidemia;
✕. Pregnant or breastfeeding women;
✕. History of other malignancies within the past 5 years;
✕. Previous history of anti-tumor treatments, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T-cell related therapies, etc.;
✕
What they're measuring
1
CR
Timeframe: pCR :within 2 weeks after surgery; cCR :2 weeks after radiotherapy ends
2
AE rate
Timeframe: During neoadjuvant chemoradiotherapy combined with immunotherapy, an average of 6 months
. History of severe neurological or psychiatric disorders (e.g., schizophrenia, dementia, or epilepsy);
✕. Current severe cardiovascular disease (heart failure or arrhythmia), renal insufficiency, or liver dysfunction; Note: Whether the patient can tolerate the specific treatment or measures should be assessed by a cardiologist based on the patient's condition.