๐ฌIn plain words
What the trial is, and whether it could suit you
This multicenter, randomized, open-label, blinded-endpoint Phase II trial assesses the efficacy and safety of tolecizumab (PCSK9 inhibitor) plus sintilimab/CapeOX chemoimmunotherapy as neoadjuvant treatment for pMMR/MSS locally advanced colon adenocarcinoma .
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Signed the written informed consent form and voluntarily participate in the study.
* Pathohistologically confirmed colon adenocarcinoma with cT3c stage or above.
* Aged 18 to 80 years, regardless of gender.
* The lower edge of the tumor is more than 10 cm from the anus.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Sufficient bone marrow, liver, kidney and coagulation functions assessed by laboratory tests (in accordance with the local laboratory reference range).
* No previous anti-tumor treatment for the current colon cancer (including radiotherapy, chemotherapy, surgery, etc.).
* No pregnancy or lactation for female patients; male patients agree to take effective contraceptive measures during the study.
Exclusion Criteria:
* Previous anti-tumor treatment for the current colon cancer.
* Previous use of PCSK9 inhibitors or PD-1/PD-L1 inhibitors.
* Active autoimmune diseases or a history of autoimmune diseases.
* Receiving immunosuppressant or systemic glucocorticoid therapy (except for local low-dose glucocorticoid use).
* Active infection requiring systemic anti-infective treatment.
* Severe cardiovascular diseases (e.g., severe hypertension, myocardial infarction, heart failure, etc.).
* Fasting LDL-C \<1.0 mmol/L (39 mg/dL), only excluding extremely low levels (suggestive of cachexia/severe hepatic disease)
* Complicated primary tumor (e.g., tumor perforation, intestinal obstruction without relief after intervention).
* Pregnant or lactating women.
* Other conditions that the investigator deems unfit for participation in the study (e.g., poor compliance, severe organ dysfunction, etc.).