Colon Cancer, MSS/pMMR, QL1706
Conditions
Keywords
Iparomlimab and Tuvonralimab, QL1706, Neoadjuvant, MSS/pMMR, Colon Cancer
Brief summary
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.
Interventions
DRUGQL1706
neoadjuvant administered at a dose of 5 mg/kg, intravenous infusion, every three weeks (Q3W), on day 1 of each cycle, 4 cycles
DRUGXELOX
Oxaliplatin 130 mg/m² by intravenous infusion on Day 1; Capecitabine 850-1000 mg/m² orally twice daily (morning and evening) from Day 1 to Day 14; 4 Cycles in total.
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response (pCR) | Approximately 1 month after surgery. | No residual viable tumor cells were found in the postoperative pathological assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Response (PR) | Approximately 1 month after surgery. | Postoperative pathology shows at least 50% tumor regression. |
| Clinical Complete Response (cCR) | Approximately 4 months after last participant enrollment. | No evidence of residual tumor is found via imaging, endoscopic examination, and clinical assessment |
| Major Pathological Response (MPR) | Approximately 1 month after surgery. | Postoperative pathology shows at least 10% tumor regression. |
| Overall Survival (OS) | Approximately 2 years after last participant enrollment. | The time from initial treatment to death from any cause |
| Adverse Event (AE) | Approximately 2 month after surgery. | Type, incidence, grading (based on NCI-CTCAE v5.0 criteria), and duration of adverse event. |
| Event-Free Survival (EFS) | Approximately 2 years after last participant enrollment. | The time from initial treatment to the occurrence of any event, including disease progression, treatment discontinuation for any reason, or death. |
Countries
China
Contacts
Primary ContactJian Wang, Dr.
Outcome results
None listed