NCT06709885招募中2 期
HDAC Inhibitor Combination with Immunochemotherapy in the Neoadjuvant Treatment of PMMR Locally Advanced Colon Cancer: a Multicenter, Double-arm, Phase II Randomized Controlled Study
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- pCR
研究概览
简要总结
The purpose of this clinical trial is to learn the safety and efficacy of HDAC inhibitors in combination with neoadjuvant immunochemotherapy compared to neoadjuvant therapy in the treatment of locally advanced colon cancer.
The main questions it aims to answer are:
Can HDAC inhibitors combined with neoadjuvant immunochemotherapy improve the rate of pCR and complete resection in patients? Are HDAC inhibitors combined with neoadjuvant immunochemotherapy safe and reliable? Does the combination of HDAC inhibitors and neoadjuvant immunochemotherapy achieve a better long-term prognosis than neoadjuvant therapy?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent to voluntarily join this study
- •Patients with colon cancer who are assessed by abdominal contrast-enhanced CT/abdominopelvic MRI as high-risk T3 (tumor destroys muscle wall and extends to pericolonic fat, protruding more than 5 mm into adjacent mesenteric fat) or T4 (tumor penetrates the visceral peritoneal surface or directly invades or adheres to adjacent organs or structures).
- •Adenocarcinoma of the colon confirmed by histopathological examination.
- •At least 18 years old, male or female.
- •Uncomplicated primary tumors (Perforation ； obstruction and bleeding that cannot be relieved by intervention)
- •The lower edge of the tumor is more than 12cm away from the anus.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate bone marrow, liver, renal, and coagulation function as assessed by the laboratory as required by the protocol
- •Have not received any anti-tumor therapy for cancer in the past, including radiotherapy, chemotherapy, surgery, etc.;
排除标准
- •History of previous allergy to monoclonal antibodies, any component of HDACi, and capecitabine;
- •Has received or is receiving any of the following treatments in the past:
- •Received any treatment against the mechanism of action of tumor immunity, such as immunization, HDACi, etc.
- •Immunosuppressive drugs, or systemic hormonal drugs within 2 weeks prior to the first use of the study drug to achieve immunosuppressive purposes
- •Receipt of a live attenuated vaccine within 4 weeks prior to the first use of study drug;
- •Major surgery or severe trauma within 4 weeks prior to the first use of study drug;
- •Receipt of systemic non-specific immunomodulatory therapy within 2 weeks prior to the first dose; Have received Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 2 weeks before the first dose.
- •Has any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism,
- •dMMR/MSI-H;
- •Presence of cardiac clinical symptoms or diseases that are not well controlled,
- •Severe infection (CTCAE > grade 2) within 4 weeks prior to the first use of study drug, with active tuberculosis infection found by medical history or CT examination,
- •Presence of active hepatitis B, hepatitis C 8.5 years of diagnosis of other malignant tumors, (adequately treated basal cell carcinoma of the skin or squamous cell skin cancer or carcinoma in situ of the cervix, etc., can be considered for enrollment);
- •Pregnant or lactating females;
- •As judged by the investigator, there are other factors that may lead to forced termination of the study, such as other serious diseases (including mental illnesses) requiring concomitant treatment, alcoholism, drug abuse, family or social factors, and factors that may affect the safety or compliance of the subject.
- •Have a history of immunodeficiency, including a positive HIV test, or have other acquired or congenital immunodeficiency disorders, or have a history of organ transplantation or allogeneic bone marrow transplantation;
研究组 & 干预措施
Chidamide + Tislelizumab + chemotherapy (CapeOX )
Experimental
4 cycles of combination therapy (q3w; Day1 Oxaliplatin, 130mg/m2, iv.gtt; tislelizumab, 200mg/m2 iv.gtt; Day1,4,8,11Chidamide 20 mg BIW,PO; Day1-Day14, capecitabine 850-1000mg/m2, BID, PO)
干预措施: Chidamide + Tislelizumab + chemotherapy (CapeOX ) (Drug)
Neoadjuvant chemotherapy (CapeOX)
Active Comparator
4 cycles Capeex (q3w; Day1 Oxaliplatin, 130mg/m2, iv.gtt; Day1-Day14, capecitabine, 850-1000mg/m2, BID, PO. ）
干预措施: CapeOX (Drug)
结局指标
主要结局
pCR
时间窗: The pCR rate will be evaluated after surgery, an average of 12 weeks
pCR was defined as the absence, from surgical samples, of malignant cells in the primary site and regional lymph nodes
次要结局
- Disease-free survival(3 years)
- Overall survival (OS)(3 years)
- MPR(From enrollment to 12 Weeks of treatment end)
- Curative resection(From enrollment to 12 Weeks of treatment end)
- ORR(From enrollment to 12 Weeks of treatment end)
- Down-staging of primary tumors(From enrollment to 12 Weeks of treatment end)
- Postoperative complications(3 years)
- Grade 3-4 adverse effects rate(From date of randomization until the date of death from any cause, assessed up to 3 years)
研究者
研究点 (1)
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