2024-516299-13-00招募中2 期
Perioperative Treatment in Resectable Gastric Cancer with Spartalizumab (PDR001) in Combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT): A phase II study (GASPAR)
Centre Francois Baclesse15 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年9月5日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 15
- 主要终点
- The primary endpoint is the proportion of patients with pCR in the primary tumour defined as: no tumour residue found in the tissue collected during the surgery evaluated by the pathologist
研究概览
简要总结
To evaluate the pathologic response after pre-operative treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized
- 主要目的
- Flot + Spartalizumab
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Subject affiliated to a social security regimen
- •Patient has signed informed consents obtained before any trial related activities and according to local guidelines
- •Untreated localized gastric or GEJ adenocarcinoma considered resectable (clinical stage ≥cT2 and/or cN+ and no metastasis)
- •Histologically confirmed adenocarcinoma
- •ECOG performance status score of 0 or 1
- •Tumor tissue must be provided for biomarker analyses (fresh or archival with an FFPE tissue block)
- •All subjects must consent to allow the acquisition of blood samples for performance of correlative studies
- •Screening laboratory values must meet the following criteria: o WBC ≥ 2000/ mm³ o Neutrophils ≥ 1500/ mm³ o Platelets ≥ 100 000/ mm³ o Hemoglobin ≥ 9.0 g/dL o Bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3 x ULN o Measured or calculated creatinine ≥ 50 ml/min clearance (CrCl) (using the Cockcroft-Gault formula) o Potassium ≥ LLN o Magnesium ≥ LLN o Calcium ≥ LLN
- •Female subject of childbearing potential must have a negative urine or serum pregnancy test within 72h before study start
- •Subject in reproductive age must be willing to use adequate contraception during the study and at least 9 months in men and 12 months in women after the last dose of investigational drug. In addition, given the toxicities observed on the male reproductive system, a conservation of gametes will be proposed for men, as usually in routine practice
排除标准
- •Subject with any distant metastasis
- •Known active HCV infection
- •Known history of active tuberculosis
- •Vaccination with live vaccine within 30 days before the first dose of study treatment
- •Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- •Recent or concomitant treatment with brivudine (herpes virostatic)
- •Prior anticancer therapy for the current malignancy
- •Known hypersensitivity to any of the study drugs or their excipients
- •Chronic inflammable gastro-intestinal disease
- •Uracilemia ≥ 16 ng/ml
- •QT/QTc > 450 msec for men and > 470 msec for women
- •Subject with no recovering from the effects of major surgery or significant traumatic injury within 14 days before inclusion
- •Peripheral neuropathy ≥ Grade II
- •Uncontrolled diabetes
- •Active infection requiring systemic therapy
- •Participation in another therapeutic clinical study
- •Patient deprived of liberty or placed under the authority of a tutor
- •Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
- •Documented significant cardiovascular disease within the past 6 months before the first dose of study treatment, including: history of congestive heart failure (defined as NYHA III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis
- •History of anterior organ transplant, including stem cell allograft
- •Pneumonitis or interstitial lung disease
- •History of other malignancy within the previous 3 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)
- •Subject with active, known, or suspected autoimmune disease
- •Subject with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment
- •Known history of HIV or HBV infection
结局指标
主要结局
The primary endpoint is the proportion of patients with pCR in the primary tumour defined as: no tumour residue found in the tissue collected during the surgery evaluated by the pathologist
The primary endpoint is the proportion of patients with pCR in the primary tumour defined as: no tumour residue found in the tissue collected during the surgery evaluated by the pathologist
次要结局
- - Disease-free survival (DFS) defined as time between inclusion and first progression according to RECIST v1.1 criteria or death whatever cause (in the absence of progression); patients without disease progression or death at the time of analysis will be censored at the time of the latest date of assessment
- - Overall survival (OS) defined as the time between inclusion and death whatever cause; any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive
- - Proportion of patients with margin-free resection (R0), defined as a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed
- - Correlation between pCR and DFS
- - Correlation between pCR and OS
- - Toxicities of the combination Spartalizumab + FLOT regimen according to NCI CTCAE criteria v5.0
- - Post-operative morbidity, defined post-operative complications grades II-V according to Clavien-Dindo classification during surgery, within 30 days after surgery or during the hospital stay
- - Post-operative mortality, defined as the rate of patients died due to any cause during the 30 days post-surgery
研究者
LECONTE Alexandra
Scientific
Centre Francois Baclesse
研究点 (15)
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