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

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

Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. Previously received any antitumor therapy for the disease under study, includingsurgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
  2. 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.
  3. Concurrent participation in another clinical study, unless participating in anobservational (non-interventional) clinical study or in the survival follow-up phaseof an interventional study.
  4. 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
    China

    Active - Recruiting

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