NCT06767449招募中不适用
Multi-center Cohort Study to Evaluate the Real-world Efficacy and Safety of Zolbetuximab Plus Chemotherapy in Claudin18.2 Positive, HER2 Negative, Advanced Gastric Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Treatment effectiveness
研究概览
简要总结
- Treatment effectiveness in the real world
- Adverse effects
- Tissue samples collected (multiplex IHC to assess PD-L1 expression, MMR gene status, and Claudin18.2)
- Blood samples collected (ctDNA, scRNAseq, or immune cell profiling)
详细描述
- Treatment effectiveness in the real world (progression-free survival, overall survival, response rate, etc.)
- Adverse effects will be evaluated according to the NCI CTCAE v5.0
- Tissue samples collected before treatment, during treatment, and at disease progression will be analyzed using multiplex IHC to assess PD-L1 expression, MMR gene status, and Claudin18.2. Additionally, NGS testing will be conducted to evaluate the correlation with the treatment response to zolbetuximab.
- Blood samples will be collected before treatment, during treatment, and after treatment completion to analyze ctDNA, scRNAseq, or immune cell profiling.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥ 19 years of age at the time of consent.
- •The patient must have histologically confirmed locally advanced, unresectable, or metastatic gastric or gastroesophageal junction adenocarcinoma
- •Patient whose tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous CLDN18 staining as determined by local or central IHC testing.
- •The tumor sample must be HER2-negative (IHC 0, 1+, or IHC 2+/ISH-).
- •The patient must have received Zolbetuximab as a first-line treatment.
- •1 Patient has ECOG performance status 0 or
- •Patient must meet all of the following criteria based on the locally analyzed laboratory tests collected.
- •Hb ≥8 g/dL (For patients who require a transfusion, it is appropriate if Hb ≥9 g/dL after transfusion)
- •ANC ≥1.0 x 10^9/L
- •Platelet ≥75 x 10^9/L
- •Total bilirubin ≤1.5 x ULN without liver metastasis, or <3.0 x ULN if liver metastasis is present
- •AST or ALT ≤2.5 x ULN without liver metastasis, or ≤5 x ULN if liver metastasis is present
- •Estimated creatinine clearance ≥30 mL/min
排除标准
- •Patient has previously received treatment in a clinical trial of zolbetuximab, or a clinical trial that included zolbetuximab as 1 of the treatment options, even if the patient was not given zolbetuximab
- •History of known or suspected hypersensitivity to Zolbetuximab, other monoclonal antibodies, or components of the used formulations.
- •Patient has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, patient may have received either neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies as long as it was completed at least 6 months prior to participation.
- •Patients who have received systemic immunosuppressive therapy, including systemic corticosteroids, within 14 days before enrollment. However, patients using physiological replacement doses of hydrocortisone or its equivalent (maximum hydrocortisone 30 mg/day or prednisone 10 mg/day), those who have received a single dose of systemic corticosteroid, or those who have received systemic corticosteroids as premedication for radiologic contrast agents are allowed.
- •Patient has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting
- •Per investigator judgment, patient has significant gastric bleeding and/or untreated gastric ulcers that would exclude the patient from participation per investigator Judgment
- •Patient has any other condition, which, in the opinion of the treating physician, makes the patient unsuitable to receive or tolerate zolbetuximab.
结局指标
主要结局
Treatment effectiveness
时间窗: 2 year
Progression-free survival, overall survival, response rate
Number of participants with treatment-related adverse events as assessed by CTCAE V5.0
时间窗: 2 year
Adverse effects will be evaluated according to the NCI CTCAE v5.0
molecular marker Analysis
时间窗: 2 year
* Tissue samples collected before treatment, during treatment, and at disease progression will be analyzed using multiplex IHC to assess PD-L1 expression, MMR gene status, and Claudin18.2. Additionally, NGS testing will be conducted to evaluate the correlation with the treatment response to zolbetuximab. * Blood samples will be collected before treatment, during treatment, and after treatment completion to analyze ctDNA, scRNAseq, or immune cell profiling.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Real-world Effectiveness and Safety of Treatment With DAAs in Patients With CHC(Chronic Hepatitis C)Chronic Hepatitis CNCT03887637Third Affiliated Hospital, Sun Yat-Sen University180
招募中
不适用
The Efficacy and Safety of Azovudine in the Treatment of COVID-19COVID-19InfectionsMoralityDeath, AssistedNCT05675761Fuzhou General Hospital500
已完成
不适用
An Observational Study of Induction Therapy With Fuzeon (Enfuvirtide) in Combination With Antiretroviral Drugs in Patients With HIV-1 InfectionHIV InfectionsNCT01902615Hoffmann-La Roche58
已完成
不适用
Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir (r) - Ombitasvir, + Dasabuvir Without Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis in the Russian FederationChronic Hepatitis CNCT03053180AbbVie60
已完成
不适用
A multi centre study to determine the efficacy and patient acceptability of scalp cooling in the prevention of docetaxel-induced hair loss.Hair lossNL-OMON26657eids Universitair Medisch Centrum in Leiden260