Short-course Radiotherapy Followed by AK112 and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer
Short-course Radiotherapy(SCRT) Followed by Ivonescimab(AK112) and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer(LARC）: A Single-arm, Single-center, Exploratory, Phase II Clinical Study
Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Pathologic complete response rate (pCR)
Time frame: though 19 weeks neoadjuvant treatment，after surgery completed
Secondary Endpoints
3-years Event-Free Survival rate
OS
R0 resection rate
Eligibility Criteria
Inclusion Criteria: 1. The subjects voluntarily joined this study, were able to complete the signing of the informed consent form, and had good compliance； 2. Age ≥18 years and ≤75 years, without gender restriction. 3. Histopathologically confirmed locally advanced rectal adenocarcinoma. 4. Participants who are not suitable for standard therapy due to intolerable toxicity, lack of standard therapy, or refusal of standard therapy. 5. Hematological parameters at baseline\* (within 7 days prior to the first dose of study drug) must meet the following criteria: • Hemoglobin ≥90 g/L • Absolute neutrophil count (ANC) ≥1.5×10\^9/L • Platelet count ≥100×10\^9/L • Eosinophils ≤1.5×upper limit of normal (ULN). \*Participants may not have received blood products (including red cell suspensions, plateletpheresis, cryoprecipitate), erythropoietin, or colony-stimulating factor supportive treatment within 7 days prior to blood sampling. 6. Serum biochemical tests at baseline (within 7 days prior to …
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