Last updated: March 11, 2024
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Overall Status: Active - Recruiting
Phase
3
Condition
Colorectal Cancer
Colon Cancer
Treatment
Sintilimab
Radical surgery
IBI310&Sintilimab
Clinical Study ID
NCT05890742
CIBI310L301
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Signed the Informed Consent Form (ICF) and complied with the visit and relatedprocedures 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 theinvestigator.
- 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
Exclusion Criteria:
- Previously received any antitumor therapy for the disease under study, includingsurgery, 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 drugacting 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 anobservational (non-interventional) clinical study or in the survival follow-up phaseof an interventional study.
- Received any investigational drug or device treatment within 4 weeks prior to initialadministration of the investigational drug.
Study Design
Total Participants: 360
Treatment Group(s): 4
Primary Treatment: Sintilimab
Phase: 3
Study Start date:
May 25, 2023
Estimated Completion Date:
July 15, 2028
Connect with a study center
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaActive - Recruiting

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