About this trial
To increase the efficacy of neoadjuvant PD-1/PD-1 checkpoint inhibitor in local advanced rectal cancer (LARC), we propose preoperative arterial infusion of Tirellizumab and oxaliplatin followed by tumor artery embolization with concurrent chemoradiotherapy as neoadjuvant regimen for LARC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Local advanced Rectal cancer: stage T3/4NanyM0 or T1-2N+M0.
Ages: 18 to 75.
No previously received chemotherapy drugs and radiation therapy.
ECOG score: 0 - 2.
Disqualifiers
Severe allergic reaction to humanized antibodies or fusion proteins;
Hypersensitivity to any component contained in contrast agent or granule embolic agent;
Diagnosed with an immune deficiency or is receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days prior to the first administration of the study, allowing the use of physiological doses of glucocorticoids (≤10mg/ day of prednisone or equivalent);
Active, known, or suspected autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hypothyroidism, including, but not limited to, these diseases or syndromes). Subjects who have type 1 diabetes, hypothyroidism requiring hormone replacement therapy, skin conditions that do not require systemic treatment (e.g., vitiligo, psoriasis, or hair loss), or conditions that are not expected to recur in the absence of external triggers may be enrolled;
Trial design
Single group
Treatments tested in this trial
CIETAI-R
Procedure/Surgery1. phase I: (1) Chemo-Immulo-embolization via Tumor Arterial, CIETAI: DSA guided tumor artery infusion of oxaliplatin 130 mg/m2+PD-1 inhibitor (Tirelizumab) 200mg, followed by gelatin sponge particles (350-560um) embolization 2. phase II: Chemoradiotherapy: IMRT:45Gy/25f/5w+capecitabine 1000,po. Bid d1-14, q3w Tirelizumab)200mg ivggt, d1, q3w
Treatment groups
Trial outcomes
Primary outcomes
Pathologic complete response (pCR)
Secondary outcomes
disease-free survival (DFS)
overall survival (OS)
Sponsors and contacts
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