SCRT Followed by AK112 in pMMR/MSS Mid-low Rectal Cancer
Short-Course Radiotherapy Followed by Ivonescimab (AK112) in pMMR/MSS Mid-Low Rectal Cancer: An Exploratory Phase II Clinical Study.
Sponsor: Zhejiang Cancer Hospital + Akeso
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Complete remission rate (CR rate)
Time frame: at the end of 6 cycles of AK112 treatment (each cycle is 21 days) or after surgery
Secondary Endpoints
Treatment - related adverse reactions
locoregional control rate
disease-free survival rate
Eligibility Criteria
Inclusion Criteria: 1. Aged between 18 and 75 years old; 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1; 3. Histopathologically confirmed rectal adenocarcinoma, without any prior anti - tumor treatment; The status of MMR/MSI is detected by IHC/PCR in pathological biopsy to clarify that the patient's classification is pMMR/MSS; 4. The lower border of the lesion is ≤ 7 cm from the anal verge as determined by fibrocolonoscopy or digital rectal examination; 5. Baseline magnetic resonance staging is cT2 - 4 and/or N+, excluding any of cT4b, N2, positive mesorectal fascia (MRF+), extramural venous invasion (EMVI+), lateral lymph node metastasis, and distant metastasis (according to the 8th edition of the AJCC Cancer Staging Manual); 6. Able to accept the treatment plan during the study period; 7. Signed written informed consent. Exclusion Criteria: 1. Uncontrolled epilepsy, history of central nervous system disorders or psychiatric conditions that, in the i…
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