QL1706 Plus XELOX as Neoadjuvant Therapy for MSS/pMMR Clinical Stage III Colon Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQilu Hospital of Shandong University

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

Treatment groups

21 Participants
are divided into 1 treatment group