MSI-H
Conditions
Keywords
dMMR, resectable colon cancer
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
Interventions
DRUGSintilimab
In ARM Phase Ib Control group, Sintilimab will be used twice, q3w.
DRUGIBI310&Sintilimab
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.
PROCEDURERadical surgery
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
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The proportion of subjects with no residual tumor in the primary tumor removed and in all lymph nodes removed after neoadjuvant therapy. |
| Event Free Survival, EFS(EFS), defined as the time from randomization to the first determination using RECIST v1.1 of inoperable disease progression, local recurrence or distant metastasis after surgery, or death from any cause, whichever occurs first. | up to 5 years after surgery | The time from randomization to the first determination using RECIST v1.1 of inoperable disease progression, local recurrence or distant metastasis after surgery, or death from any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| R0 tumor resection rate, defined as the proportion of subjects with R0 excision | 2 week after surgery | The proportion of subjects with R0 excision |
| Overall-survival(OS), defined as the time from randomization to death from any cause | up to 5 years after surgery | The time from randomization to death from any cause |
Countries
China
Outcome results
None listed