At a glance
ClinicalIndex Comparison Record- ✓Age 18-75 years
- ✓ECOG performance status 0-2
- ✓Biopsy-confirmed rectal adenocarcinoma with distal margin ≤10 cm from anal verge
- ✓Stage II or III (excluding T4b) without distant metastasis by MRI
- ✕Multiple cancers or concomitant malignant tumors besides rectal cancer
- ✕Any prior anti-cancer treatment (surgery, chemotherapy, radiation, immunotherapy, biological therapy, herbal therapy)
- ✕Prior anti-cancer treatment within 5 years
- ✕Recent major surgery
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05245474Phase 2RecruitingUpdate OverdueUpdated 29mo ago · Completion was 28mo agoEfficacy and Safety of Neoadjuvant Long-course Chemoradiation Plus Tislelizumab in Mid-low Locally Advanced Rectal Cancer: a Phase II, Multi-center, Open-label, Randomized Controlled Trial (POLARSTAR Trial)
In Brief
A Phase 2 clinical trial evaluating Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor) for Locally Advanced Rectal Cancer. Currently recruiting, targeting 186 participants across 8 sites.
Signals
Detailed Summary
This is a phase II/III, multi-center, open-label, 3-arm, randomized controlled trial assessing the efficacy and safety of neoadjuvant long-course chemoradiation combined with Tislelizumab (PD-1 inhibitor) and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+concurrent PD-1 inhibitor; Experiment group 2: chemoradiation+sequential PD-1 inhibitor) with a control group (chemoradiation only).
Study Details
Timeline
Interventions
Tislelizumab is added to long-course chemoradiation (CRT) of LARC patients, with CRT+concurrent Tislelizumab for Arm 1, CRT+sequential Tislelizumab for Arm 2, and CRT only for Arm 3