Colon Cancer
Conditions
Brief summary
The goal of this clinical trial is to evaluate the efficacy of neoadjuvant QL1706 in participants with untreated T4N0 or Stage III (resectable), microsatellite instability high/ defective mismatch repair (MSI-H/dMMR) colon cancer
Interventions
DRUGQL1706
Phase Ib/Ⅲ： QL1706 will be administered
DRUGCAPEOX/Capecitabine
Phase Ⅲ：CAPEOX/Capecitabine will be administered
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Signed written informed consent; * Eastern Cooperative Oncology Group Performance Status of 0 or 1 * Untreated pathologically confirmed colon adenocarcinoma * Radiographic assessment showed a resectable stage IIB-III based on AJCC Stage VIII (cT4 or cN+ only). * Has a tumor demonstrating the presence of MSI-H/ dMMR * Adequate organ function as described in the protocol
Exclusion criteria
* Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc * Has distant metastatic disease. * Has an active autoimmune disease that has required systemic treatment in past 2 years * Has know history of, or any evidence of interstitial lung disease; * Has an active infection requiring systemic therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Event Free Survival, EFS(EFS), defined as the time from randomization to either disease recurrence or death due to any cause or treatment related toxicity that results in the participant not being suitable for surgery. | Up to approximately 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to approximately 5 years | OS is defined as time from randomization to death from any cause |
| R0 tumor resection rate | 2 week after surgery | R0 tumor resection rate is defined as the proportion of subjects with R0 excision |
| Number of Participants with treatment emergent adverse events (AEs), serious adverse events (SAEs), Immune-mediated Adverse Event (imAEs), AEs leading to death and AEs leading to discontinuation of study treatment | Up to approximately 5 years | — |
Countries
China
Contacts
Primary ContactRuihua Xu, PhD
Outcome results
None listed