At a glance
ClinicalIndex Comparison Record- ✓Age 18-75 years
- ✓Treatment-naive patients with histological or cytological documentation of rectal adenocarcinoma <12 cm from anal verge
- ✓Clinical stage T3/T4 or N positive, M0, before nCRT
- ✓Non-complicated primary tumor (no complete obstruction, perforation, or bleeding)
- ✕Prior malignancy within past 5 years (except basal cell or squamous cell skin cancer)
- ✕Arterial thrombotic event within past 6 months (angina, MI, TIA, CVA)
- ✕Active lung disease (interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or active tuberculosis
- ✕Uncontrollable clinical problems including active autoimmune disease, uncontrolled diabetes, uncontrolled hypertension, heart failure grade III/IV, or severe infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05450029Phase 2RecruitingUpdate OverdueUpdated 33mo ago · Completion was 29mo agoNeoadjuvant Chemoradiotherapy Plus Sintilimab for Intermediate/High Immunoscore Locally Advanced Rectal Cancer: A Single-Center, Open-Label, Single-Arm, Phase 2 Trial
In Brief
A Phase 2 clinical trial evaluating Sintilimab for Rectal Cancer. Currently recruiting, targeting 51 participants across 1 site.
Signals
Detailed Summary
Immunoscore has been reported to be superior to microsatellite instability staging in predicting the disease-specific recurrence and survival for patients with colorectal cancer. However, the relationship between Immunoscore and its impact on patient's response to PD-1 blockade remains to be elucidated. This phase II, prospective, open label study is designed to evaluate the efficacy and safety of combination neoadjuvant chemoradiotherapy (nCRT) with the anti-PD-1 antibody sintilimab for intermediate/high Immunoscore locally advanced rectal cancer.
Study Details
Timeline
Interventions
6 cycles of mFOLFOX6 (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by bolus 5-fluorouracil 400 mg/m2 and 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) followed by long course chemoradiotherapy (50 Gy in 25 fractions) followed by surgery. Patients will receive sintilimab 3mg/kg every 2 weeks during chemoradiotherapy (2nd-6th cycle).