About this trial
This is a single-arm, exploratory study enrolling participants with resectable stage III pMMR/MSS colon cancer. Eligible participants who provide written informed consent will receive four cycles of neoadjuvant treatment with iparomlimab and tuvonralimab (QL1706) plus XELOX regimen administered every three weeks (Q3W), followed by radical surgery within two weeks after the last neoadjuvant treatment. After surgery, participants will enter the follow-up phase, or clinicians may decide to administer four additional cycles of adjuvant XELOX chemotherapy based on postoperative pathological findings. The primary endpoint of this study is the pathological complete response (pCR) rate as assessed by investigators. Other endpoints include pathological response (PR), major pathological response (MPR), clinical complete response (cCR), event-free survival (EFS), overall survival (OS), and safety.
Eligibility criteria
Qualifiers
Age between 18 and 75 years.
Histologically or clinically confirmed initially resectable Stage III colon cancer according to the AJCC 8th edition.
ECOG performance status of 0 or 1.
pMMR/MSS status confirmed by a local testing center.
Disqualifiers
Stage IV colon cancer.
Prior treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1, or PD-L1.
Current participation in another clinical trial and receiving investigational drugs.
History of or contraindication to severe allergic reactions to immunotherapy.
Trial design
Treatments tested in this trial
- QL1706
- XELOX