To investigate the efficacy and safety of short-course radiotherapy sequential fruquintinib in combination with adebrelimab and CAPOX (full course neoadjuvant therapy) in patients with locally advanced rectal cancer.
Signed written informed consent and volunteered to participate in the study;
Age 18-75 years old (including the cut-off value), male or female;
Locally advanced rectal adenocarcinoma confirmed by histopathology;
Clinical tumor (cT) stage cT4a or cT4b (according to the AJCC, 8th edition)
Previous allergic history to any anti-angiogenesis targeted drug, any component of monoclonal antibody, capecitabine, oxaliplatin, or other platinum drugs;
being treated with an immunosuppressive drug, or systemic hormone, for immunosuppression within 2 weeks before the first dose of the study drug (dose> 10mg/ day prednisone or equivalent); Inhaled or topical steroid use and dosage are allowed in the absence of active autoimmune disease; Prednisone 10mg/ day or equivalent dose of adrenocortical hormone replacement;
received live attenuated vaccine within 4 weeks before the first dose of study drug;
major surgery or severe trauma within 4 weeks before the first dose of study drug;
Single group
Fruquintinib, Adebrelimab, Oxaliplatin, Capecitabine
DrugSafety run-in phase: Fruquintinib 4mg/d, oral, once daily, continuous treatment for 2 weeks, 1 week off, q3w, 6 cycles; If the number of patients experiencing dose-limiting toxicity (DLT) was ≤1, the study would continue at that dose level. If the number of patients with DLTs was \>1, the dose of fruquintinib was decreased to 3mg/d, qd po, d1-14, q3w, and the dose expansion phase was continued；Adebrelimab 1200mg, d1, IV infusion, q3W, 6 cycles; Capecitabine 1000 mg/m2, twice a day, po, d1-14, followed by 7 days of rest, q3W, 6 cycles; Oxaliplatin 130 mg/m2, d1, q3W, 6 cycles; Dose expansion phase: Fruquintinib RP2D, qd po, d1-14, q3w, 6 cycles; Adebrelimab 1200mg, d1, IV infusion, q3W, 6 cycles; Capecitabine 1000 mg/m2, twice a day, po, d1-14, followed by 7 days of rest, q3W, 6 cycles; Oxaliplatin 130 mg/m2, d1, q3W, 6 cycles;
pathology complete response(pCR)
The proportion of subjects with no residual viable tumor cells(ypT0N0) in the primary tumor and lymph nodes, also defined as the proportion of subjects with grade 0 in the AJCC Tumor Regression Grading (TRG) scoring system(version 8.0).
3-year Event-Free Survival(EFS) rate
The percentage of patients without disease recurrence or progression or death due to any cause after 3-year follow-up
Overall Survival(OS)
The time from the date of randomization to the death caused by any cause
R0 resection rate
The rate of negative margin microscopically
Adverse events (AEs)
Adverse events (AEs) were graded according to the NCI CTCAE version 5·0
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Renmin Hospital of Wuhan University
Collaborator
