NCT06940778进行中（未招募）不适用
LIQUID BIOPSY FOCUSING ON CIRCULATING TUMOR CELLS (CTC) AND CIRCULATING TUMOR DNA (CTDNA) AS A PRECISION MEDICINE TOOL IN GASTROINTESTINAL TUMORS
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 273
- 试验地点
- 1
- 主要终点
- disease free survival
研究概览
简要总结
This is a prospective, observational, multicenter cohort study. Our main objective is to to evaluate the use of CTCs and ctDNA with prognostic factors in locally advanced rectal tumors treated with total neoadjuvant therapy (TNT), recently adopted as clinical practice, and to analyze the functionality of CTCs and ctDNA in the follow-up of locally advanced and metastatic pancreatic and gastric tumors.
Secondary objectives:
- To verify the influence of CTC and ctDNA kinetics on the response to treatment of the three tumors;
- To correlate RAD23B/TYMS findings and CTC kinetics with DFS in locally advanced rectal tumors;
- To correlate HER-2 and PDL-1 expression in CTCs in gastric cancer with progression-free and overall survival;
- To verify the correlation between EGFR methylation in ctDNA of metastatic gastric tumors and PFS and OS;
- Correlate KRAS mutations in ctDNA in locally advanced pancreatic and rectal cancer with progression-free and overall survival;
- Compare the mutational profile of the primary tumor with that of the main components of the liquid biopsy (CTCs and ctDNA), in the three disease scenarios.
详细描述
To evaluate CTCs we will isolate cells from blood of patients by ISET method (Rarecells, France). The DNA from CTCs will be evaluated by digital PCR (Qiagen). Also, the ctDNA. Patients will be evaluated three times ( before the beginning of therapy, 6 and 12 months later. The study will be only observational. Patients will be followed by clinical and images exams.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •Age ≥ 18 years;
- •For locally advanced rectal cancer:
- •Patients with histological confirmation of adenocarcinoma of the distal rectum who are candidates for sphincter preservation and undergoing TNT, a long-course CRT regimen, followed by CT (5-FU + consolidation oxaliplatin);
- •Tumors with a location that requires rectal amputation, except for very early tumors (cT1N0);
- •Absence of distant metastases (M0).
- •For locally advanced or metastatic stomach cancer:
- •Patients with histological confirmation of adenocarcinoma of the stomach or esophagogastric junction (EGJ) (cT2-4, cN0-3, M0-1) who have not undergone any previous treatment for the disease, surgical or systemic;
- •Patients who will undergo the following treatments:
- •(T2 to T4, N+ and M0): 4 cycles of FLOT, surgery, + 4 cycles of FLOT (5-Fluorouracil, Oxaliplatin and Docetaxel);
- •Initial cases: T2 to T4 N0: Surgery followed by adjuvant chemotherapy: CAPOX (capecitabine + oxaliplatin) or FOLFOX (5-Fluorouracil + capecitabine) - 8 cycles;
- •Initially unresectable T4N3: If PDL1+ and CPS > 5: CT (FOLFOX or XELOX) + nivolumab. If HER-2 + XELOX or FOLOFX + transtuzumab - after 8 cycles evaluate resectability;
- •Metastatic disease: if HER2 negative - XELOX or FOLFOX with Nivolumab or pembrolizumab. If HER2 positive XELOX or FOLFOX with trastuzumab + pembrolizumab.
- •For localized or metastatic pancreatic cancer:
- •Patients with histologically confirmed pancreatic adenocarcinoma (cT1-4, N0-2, M0-1) who have not undergone any prior surgical or systemic treatment for the disease.
- •Patients who will undergo the following treatments:
- •T1 to T3, N0 to N2 - resectable: Surgery followed by 12 cycles of FOLFIRINOX (oxaliplatin, 5-fluorouracil and irinotecan)
- •Borderline resectable: Neoadjuvant chemotherapy with FOLFIRINOX for 8 cycles and surgery
- •Unresectable disease - locally advanced: FOLFIRINOX for 12 cycles or Gemcitabine + nanoparticle paclitaxel for 8 cycles
排除标准
- •Mid-rectum tumors or tumors with microsatellite instability.
- •Stomach tumors or early EGJ (cT1N0)
- •Patients who have undergone prior treatment or any surgical intervention in the last 30 days.
结局指标
主要结局
disease free survival
时间窗: from baseline (day 1) until the date of first documented progression , assessed up to 24months
from the diagnosis of advanced disease to disease progression
次要结局
- overall survival(from the day one until the date of death from any cause, assessed up to 30 months)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Establishment of a Microfluidic Based Liquid Biopsy Platform for Recurrent/Metastatic Head and Neck Cancers Prognostication Using NK Cell IFN-γ Expression and CTM Correlation With DS-SACA ChipHead and Neck Cancers- Squamous CellHead and Neck Cancer MetastaticRecurrent Head and Neck Squamous Cell CarcinomaNCT06678724National Taiwan University Hospital30
尚未招募
不适用
Liquid Biopsy for the Diagnosis of Intestinal-type Adenocarcinoma of the Ethmoid (BLADE)Ethmoid Sinus TumorAdenocarcinomaCirculating Tumor CellNCT06090214University Hospital, Montpellier42
尚未招募
不适用
Identification and Characterization of Circulating Tumor Cells Before and After Treatment (Surgery and Radiotherapy) in a Cohort of Patients Treated for Resectable Stage I-III Merkel Cell CarcinomaMerkel Cell CarcinomaNCT06448611University Hospital, Montpellier25
Unknown
不适用
Identification and Evaluation of Circulating Tumor Cells and Tumor Related Rare Cells in ImmunotherapyCTC and Tumor Related Rare CellNCT03434912MiCareo Taiwan Co., Ltd.80
Unknown
不适用
Construction and Evaluation of the Liquid Biopsy-based Early Diagnostic Model for Lung CancerHealthyPulmonary NoduleNCT04156360Shanghai Pulmonary Hospital, Shanghai, China150