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

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY ·

Keywords

ClinConnect Summary

This is a early-stage, single-arm study testing a new pre-surgery treatment approach for a specific type of colon cancer. Researchers are looking at whether giving two immune-drug antibodies (QL1706, a combination of iparomlimab and tuvonralimab) together with standard chemotherapy (XELOX) before surgery can increase the chance of completely eradicating the cancer in the tissue removed during surgery. The plan is four cycles every three weeks, followed by surgical removal of the tumor within about two weeks after the last treatment. After surgery, patients may receive up to four more cycles of XELOX depending on the pathology results. The main goal is to see how many people have a pathological complete response (no cancer cells) in the surgical specimen, with several additional outcomes including other levels of tumor response, survival, and safety.

Eligibility is for adults aged 18 to 75 with resectable Stage III colon cancer that is MSS/pMMR (not a specific genetic subtype called microsatellite instability), and a good overall health status (ECOG 0–1). Participants should not have had prior treatment with immune checkpoint drugs, should not have planned radiation before surgery, and must have adequate organ function and the ability to consent. Key exclusions include metastatic (Stage IV) cancer, pregnancy, active infection or serious heart conditions, recent major surgeries or other conditions that would make participation unsafe. The trial is being conducted at Qilu Hospital of Shandong University in Jinan, China, is not yet recruiting, plans to enroll about 21 people, and aims to start around September 2025, with results hoped later to inform future research.

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ALL

Eligibility criteria