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

Shandong University

Status and phase

Not yet enrolling

Phase 2

Conditions

MSS/pMMR

Colon Cancer

QL1706

Treatments

Drug: XELOX

Drug: QL1706

Study type

Interventional

Funder types

Other

Identifiers

NCT07156682

KYLL-202502-005-1

Details and patient eligibility

About

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.

Enrollment

21 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.
No planned neoadjuvant radiotherapy.
Participants must voluntarily participate in the study, sign an informed consent form, and demonstrate good compliance.
Adequate organ function.

Exclusion criteria

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.
Pregnancy or lactation.
Active infection requiring treatment.
Use of immunosuppressive medications.
Active cardiovascular disease, including stroke or myocardial infarction within 6 months before enrollment, unstable angina, congestive heart failure, or severe uncontrolled arrhythmia requiring medication that may preclude surgery.
Patients with acute conditions such as obstruction, hemorrhage, or perforation that require immediate surgery.
Any other condition deemed by the investigator to render the participant unsuitable for the clinical study.