Short-course Radiotherapy Followed by Fruquintinib Plus Adebrelimab and CAPOX in the Full Course Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Multicenter, Single-arm, Open-label Study

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Fruquintinib, Adebrelimab, Oxaliplatin, Capecitabine

Treatment groups

45 Participants
are divided into 1 treatment group

Sponsors and collaborators