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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1706 + XELOX | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1706 | Drug | neoadjuvant administered at a dose of 5 mg/kg, intravenous infusion, every three weeks (Q3W), on day 1 of each cycle, 4 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response (pCR) | No residual viable tumor cells were found in the postoperative pathological assessment. | Approximately 1 month after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Major Pathological Response (MPR) | Postoperative pathology shows at least 10% tumor regression. | Approximately 1 month after surgery. |
| Pathological Response (PR) | Postoperative pathology shows at least 50% tumor regression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Wang, Dr. | Contact | +86 18560088226 | wang.jian@sdu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jing Hao, Deputy Director, Department of Oncology, MD, PhD | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu hospital of Shandong University | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| C519688 | XELOX |
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| XELOX | Drug | 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. |
|
| Approximately 1 month after surgery. |
| Clinical Complete Response (cCR) | No evidence of residual tumor is found via imaging, endoscopic examination, and clinical assessment | Approximately 4 months after last participant enrollment. |
| Event-Free Survival (EFS) | The time from initial treatment to the occurrence of any event, including disease progression, treatment discontinuation for any reason, or death. | Approximately 2 years after last participant enrollment. |
| Overall Survival (OS) | The time from initial treatment to death from any cause | Approximately 2 years after last participant enrollment. |
| Adverse Event (AE) | Type, incidence, grading (based on NCI-CTCAE v5.0 criteria), and duration of adverse event. | Approximately 2 month after surgery. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |