NCT07580339尚未招募2 期
Combining CD93 Inhibition (DCSZ11) With Short Course Radiation and Chemotherapy as Part of Total Neoadjuvant Treatment (TNT) for High-risk Mismatch Repair Proficient (pMMR) Locally Advanced Rectal Cancer (LARC)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to evaluate the safety and clinical activity of combining DCSZ11 with radiation and capecitabine/oxaliplatin (CAPOX) for the neoadjuvant treatment of patients with mismatch repair proficient (pMMR) high risk locally advanced rectal cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 -
- •Rectal cancer (with tumor tissue present at or below the peritoneal reflection) as determined by MRI pelvis or endoscopic ultrasound.
- •Have histologically proven mismatch repair proficient (pMMR) or microsatellite stable (MSS) rectal adenocarcinoma.
- •Must not have received any prior systemic treatment or radiation.
- •Patients have the following clinical staging:
- •cT4 any node status
- •Any T stage cN2 node status
- •Any T or N status, evidence of suspicious lateral lymph nodes > 10 mm in size in short axis
- •Evidence of extramural vascular invasion on MRI pelvis
- •Absence of distant metastases on CT or MRI imaging
- •Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.
- •Left ventricular ejection fraction (LVEF) assessment with documented LVEF ≥ 50% by either TTE or Multigated Acquisition (MUGA) (TTE preferred) within 6 months from first study drug administration.
- •For both Women and Men, must use acceptable form of birth control while on study.
- •Ability to understand and willingness to sign a written informed consent document.
排除标准
- •Have received an investigational agent or used an investigational device within 28 days of the first dose of study drug.
- •Have expected to require any other form of systemic or localized antineoplastic therapy while on study.
- •Have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.).
- •History of severe hypersensitivity reaction to any monoclonal antibody.
- •History of encephalitis, meningitis, dementia, Parkinson's or uncontrolled seizures within 1 year prior to the first dose of study drug.
- •Uncontrolled infection of HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), or Tuberculosis.
- •Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft.
- •Patient has a pulse oximetry of <92% on room air.
- •Patient is on supplemental home oxygen.
- •Has clinically significant heart disease.
- •Conditions, including alcohol or drug dependence that would affect the patient's ability to comply with study visits and procedures.
- •Patient is pregnant or breastfeeding.
- •Unwilling or unable to follow the study schedule for any reason.
- •Patient received a live vaccine within 30 days of planned start of study medication.
- •Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication.
研究组 & 干预措施
DCSZ11 with Chemotherapy
Experimental
干预措施: Radiation (Radiation)
DCSZ11 with Chemotherapy
Experimental
干预措施: DCSZ11 (Drug)
DCSZ11 with Chemotherapy
Experimental
干预措施: Oxaliplatin (Drug)
DCSZ11 with Chemotherapy
Experimental
干预措施: Capecitabine (Drug)
研究者
研究点 (1)
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