NCT07156682Not yet recruitingPhase 2
QL1706 Plus XELOX as Neoadjuvant Therapy for MSS/pMMR Clinical Stage III Colon Cancer
A Single-Arm, Exploratory Study of Iparomlimab and Tuvonralimab (QL1706) Plus XELOX as Neoadjuvant Therapy in Patients With Microsatellite Stable (pMMR/MSS) Resectable Stage III Colon Cancer
Source: ClinicalTrials.gov · Last updated 5 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- First submitted
- 27 Aug 2025
- Start date
- 25 Sept 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Qilu Hospital of Shandong University
- Diseases
- Colorectal cancer
- NCT number
- NCT07156682
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 21
- From 25 Sept 2025 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1, or PD-L1.
- Current participation in another clinical trial and receiving investigational drugs.
- 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.
Other illness
- Stage IV colon cancer.
- History of or contraindication to severe allergic reactions to immunotherapy.
- Active infection requiring treatment.
- 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.
Other
- Pregnancy or lactation.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.