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Perioperative Treatment in Resectable Gastric Cancer with Spartalizumab (PDR001) in Combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT): A phase II study (GASPAR)
EU CTIS ID: 2024-516299-13-00
What this study is testing
To evaluate the pathologic response after pre-operative treatment
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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
You likely can't join if
- - 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)
See the full eligibility criteria
Who can join
- - 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
What rules you out
- - 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.