A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer

Inclusion criteria

• Signed the Informed Consent Form (ICF) and complied with the visit and related procedures stipulated by the plan;
• At least 18 years old.
• Primary colon adenocarcinoma was histologically confirmed.
• Radiographic assessment showed a resectable stage IIB-III based on AJCC Stage VIII (cT4 or cN+ only).
• MSI-H or dMMR.
• Radical excision can be performed before neoadjuvant therapy after diagnosis by the investigator.
• Have at least one evaluable lesion according to the RECIST v1.1 evaluation criteria.
• The Eastern Cooperative Oncology Group performance status (ECOG PS) is 0 to 1.

Exclusion criteria

• Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
• Prior treatment with anti-PD-1, anti-PD-L1, anti-programmed death receptor ligand 2 (PD-L2) or anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) or any other drug acting on T-cell co-stimulation or immune checkpoint pathways (such as OX40, CD137, etc.) and adoptive cellular immunotherapy.
• Concurrent participation in another clinical study, unless participating in an observational (non-interventional) clinical study or in the survival follow-up phase of an interventional study.
• Received any investigational drug or device treatment within 4 weeks prior to initial administration of the investigational drug.