NCT07656740尚未招募不适用
Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers (NOMIC Trial)
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年6月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
This is a single-center, bidirectional (retrospective and prospective) registry study aimed at evaluating the safety and efficacy of Non-Operative Management (NOM) and Organ-Preserving Functional Surgery (OPFS) in patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) or POLE-mutated gastrointestinal (GI) cancers who received neoadjuvant immunotherapy.Patients achieving a clinical complete response (cCR) or near-cCR may undergo a "Watch & Wait" (W&W) strategy, while those with near-cCR or non-cCR ($\le ymrT2N0$) may undergo local excision (LE) or endoscopic resection (ESD/EMR). Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Retrospective Cohort Inclusion Criteria
- •Pathologically confirmed gastrointestinal malignancy determined as MSI-H/dMMR or POLE mutation, and initially resectable.
- •Completed prior immunotherapy.
- •No evidence of distant metastasis.
- •Managed with W&W, LE, endoscopic surgery, or radical operation after treatment.
- •Prospective Cohort Inclusion Criteria
- •Pathologically confirmed gastrointestinal malignancy determined as MSI-H/dMMR or POLE mutation, and initially resectable.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Immunotherapy status: naive, currently receiving, or completed treatment, and evaluated by the PKUCH-NOMIC research group as cCR/near-cCR or Non-cCR (≤ ymrT2N0).
- •No evidence of distant metastasis.
- •Absence of emergencies requiring immediate surgery (e.g., hemorrhage, perforation, obstruction).
排除标准
- •Recurrent gastrointestinal tumors.Initial presence of unresectable distant metastases.
- •Serum creatinine > 1.5 times upper limit of normal (ULN).
- •History of pelvic radiation therapy.Inability to tolerate MRI examinations.
- •History of other malignancies within the past 5 years with a survival rate significantly lower than the historical rectal cancer survival data of this center (except adequately treated basal cell carcinoma, cutaneous squamous cell carcinoma, small renal cell carcinoma, breast cancer, and papillary thyroid carcinoma).
- •Arterial thromboembolic events within the past 6 months (e.g., angina, myocardial infarction, transient ischemic attack [TIA], cerebral vascular accident [CVA]).
- •Prior receipt of other types of investigational anti-tumor therapies.
- •Pregnant or lactating women.
- •Concomitant diseases or mental health conditions that may interfere with study participation.
研究者
Xiaokang Lei
Principal Investigator
Peking University Cancer Hospital & Institute
研究点 (1)
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