Status:
NOT_YET_RECRUITING
SCRT Followed by AK112 in pMMR/MSS Mid-low Rectal Cancer
Lead Sponsor:
Zhejiang Cancer Hospital
Collaborating Sponsors:
Akeso
Conditions:
Rectal Cancer
Radiation
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Primary Objectives： Evaluate the complete response rate (CR rate) and safety of short - course radiotherapy combined with ivonesimab (AK112) in patients with pMMR/MSS mid - low rectal cancer. Seconda...
Eligibility Criteria
Inclusion
- Aged between 18 and 75 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1;
- 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;
- The lower border of the lesion is ≤ 7 cm from the anal verge as determined by fibrocolonoscopy or digital rectal examination;
- 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);
- Able to accept the treatment plan during the study period;
- Signed written informed consent.
Exclusion
- Uncontrolled epilepsy, history of central nervous system disorders or psychiatric conditions that, in the investigator's judgment, may interfere with the ability to provide informed consent or affect compliance with oral medication.
- Prior immunotherapy for any indication or a history of severe hypersensitivity reactions to other monoclonal antibodies.
- Clinically significant active cardiac disease, including symptomatic coronary artery disease, congestive heart failure (New York Heart Association \[NYHA\] Class II or higher), severe arrhythmias requiring medication, or a history of myocardial infarction within the past 12 months.
- Immunosuppressive therapy following organ transplantation.
- History of other malignancies within the past 5 years (excluding adequately treated non-melanoma skin cancer or carcinoma in situ).
- Severe uncontrolled recurrent infections or other significant uncontrolled comorbidities.
- Baseline laboratory values failing to meet the following criteria:Hemoglobin ≥80 g/L; Absolute neutrophil count (ANC) ≥1.5×10\^9/L; Platelets ≥100×10\^9/L; ALT/AST ≤2.5×upper limit of normal (ULN); Alkaline phosphatase (ALP) ≤2.5×ULN; Total bilirubin \<1.5×ULN; Serum creatinine \<1×ULN
- Active gastrointestinal diseases (e.g., gastric/duodenal ulcers, ulcerative colitis), unresected tumors with active bleeding, or other conditions deemed by the investigator to pose risks of gastrointestinal bleeding or perforation.
- Active bleeding or bleeding predisposition.
- Pregnancy or lactation.
- Hypersensitivity to any component of the investigational drug(s).
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07162714
Start Date
September 1 2025
End Date
December 31 2028
Last Update
September 9 2025
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