CAPEOX/Capecitabine: Phase Ⅲ：CAPEOX/Capecitabine will be administered
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
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
Primary outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
Affiliated Cancer Hospital of Sun Yat-sen University
Guangzhou
China
Recruiting
More Qilu Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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