At a glance
ClinicalIndex Comparison Record- ✓Locally advanced rectal cancer stage T3/4NanyM0 or T1-2N+M0
- ✓Age 18 to 75 years
- ✓No prior chemotherapy or radiation therapy
- ✓ECOG performance status 0-2
- ✕Severe allergic reaction to humanized antibodies or fusion proteins
- ✕Hypersensitivity to contrast agent or embolic agent components
- ✕Immune deficiency or receiving immunosuppressive therapy within 14 days
- ✕Active or suspected autoimmune diseases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05957016Phase 2RecruitingUpdate OverdueUpdated 34mo ago · Completion was 12mo agoNeoadjuvant Preoperative Arterial Intervention With Concurrent Chemoradiotherapy in Local Advanced Rectal Cancer
In Brief
A Phase 2 clinical trial evaluating CIETAI-R for Rectal Cancer. Currently recruiting, targeting 90 participants across 1 site.
Signals
Detailed Summary
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.
Study Details
Timeline
Interventions
1. 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