A Study of Neoadjuvant QL1706 in Participants With Untreated dMMR/MSI-H Resectable Colon Cancer
Recruiting · NCT06686576 · Interventional (participants receive a specific treatment) · Lead sponsor: Qilu Pharmaceutical Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
CAPEOX/CapecitabineQL1706
What this trial is about
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
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Affiliated Cancer Hospital of Sun Yat-sen University - Guangzhou, China