A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer
Study Details
Study Description
Brief Summary
Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Ib Experimental group
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Drug: IBI310
In arm 1,IBI310 will be used once
Procedure: Radical surgery
Radical surgery after neoadjuvant therapy
Drug: Sintilimab
In arm1&2,Sintilimab will be used twice ,q3w
|
Active Comparator: Ib Control group
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Procedure: Radical surgery
Radical surgery after neoadjuvant therapy
Drug: Sintilimab
In arm1&2,Sintilimab will be used twice ,q3w
|
Outcome Measures
Primary Outcome Measures
- Pathological Complete Response(pCR), defined as the proportion of subjects with no residual tumor in the primary tumor removed and in all lymph nodes removed after neoadjuvant therapy. [1 month after surgery]
Secondary Outcome Measures
- Major Pathological Response, MPR, defined as the proportion of subjects with ≤ 10% residual survivable tumor in the removed primary tumor after neoadjuvant therapy [1 month after surgery]
- Event Free Survival, EFS, defined as the time from randomization until first determined by RECIST v1.1 to be inoperable disease progression, local recurrence or distant metastasis after surgery, or death from any cause, whichever occurs first [3 years after surgery]
- R0 tumor resection rate, defined as the proportion of subjects with R0 excision [1 week after surgery]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed the Informed Consent Form (ICF) and complied with the visit and related procedures stipulated by the plan;
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At least 18 years old.
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Primary colon adenocarcinoma was histologically confirmed.
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Radiographic assessment showed a resectable stage IIB-III based on AJCC Stage VIII (cT4 or cN+ only).
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MSI-H or dMMR.
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Radical excision can be performed before neoadjuvant therapy after diagnosis by the investigator.
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Have at least one evaluable lesion according to the RECIST v1.1 evaluation criteria.
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The Eastern Cooperative Oncology Group performance status (ECOG PS) is 0 to 1.
Exclusion Criteria:
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Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
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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.
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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.
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Received any investigational drug or device treatment within 4 weeks prior to initial administration of the investigational drug.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | China | 510060 |
Sponsors and Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIBI310L301