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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Pathological Complete Response (pCR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •Stage IV colon cancer.
- •Prior treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1, or PD-L
- •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.
研究组 & 干预措施
QL1706 + XELOX
干预措施: QL1706 (Drug)
QL1706 + XELOX
干预措施: XELOX (Drug)
结局指标
主要结局
Pathological Complete Response (pCR)
时间窗: Approximately 1 month after surgery.
No residual viable tumor cells were found in the postoperative pathological assessment.
次要结局
- Major Pathological Response (MPR)(Approximately 1 month after surgery.)
- Pathological Response (PR)(Approximately 1 month after surgery.)
- Clinical Complete Response (cCR)(Approximately 4 months after last participant enrollment.)
- Event-Free Survival (EFS)(Approximately 2 years after last participant enrollment.)
- Overall Survival (OS)(Approximately 2 years after last participant enrollment.)
- Adverse Event (AE)(Approximately 2 month after surgery.)
研究者
Jing Hao
Deputy Director, Department of Oncology
Qilu Hospital of Shandong University