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Trial Title:
A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer
NCT ID:
NCT05890742
Condition:
MSI-H
Conditions: Official terms:
Colonic Neoplasms
Conditions: Keywords:
dMMR
resectable colon cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sintilimab
Description:
In ARM Phase Ib Control group, Sintilimab will be used twice, q3w.
Arm group label:
Phase Ib Control group
Intervention type:
Drug
Intervention name:
IBI310&Sintilimab
Description:
In ARM Phase Ib&III Experimental group，IBI310&Sintilimab will be used in first cycle,
Sintilimab will be used in second cycle(q3w). Radical surgery after neoadjuvant therapy.
Arm group label:
Phase III Experimental group
Arm group label:
Phase Ib Experimental group
Intervention type:
Procedure
Intervention name:
Radical surgery
Description:
In ARM Phase Ib&III Experimental group, Phase Ib Control group, subjects will receive
radical surgery after neoadjuvant therapy. In ARM Phase III Control group,subjects will
receive radical surgery without neoadjuvant therapy
Arm group label:
Phase III Control group
Arm group label:
Phase Ib Control group
Arm group label:
Phase Ib Experimental group
Summary:
Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab,
for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Signed the Informed Consent Form (ICF) and complied with the visit and related
procedures 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 the
investigator.
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 Criteria:
1. Previously received any antitumor therapy for the disease under study, including
surgery, 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
drug acting 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 an
observational (non-interventional) clinical study or in the survival follow-up phase
of an interventional study.
4. Received any investigational drug or device treatment within 4 weeks prior to
initial administration of the investigational drug.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Ruihua Xu
Phone:
+86-20-87343533
Email:
xurh@sysucc.org.cn
Start date:
May 25, 2023
Completion date:
July 15, 2028
Lead sponsor:
Agency:
Innovent Biologics (Suzhou) Co. Ltd.
Agency class:
Industry
Source:
Innovent Biologics (Suzhou) Co. Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05890742
