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Gastric Cancer by AJCC V8 StagePhase 2GASPARNCT04736485

Perioperative Treatment in Resectable Gastric Cancer With Spartalizumab (PDR001) in Combination With Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel (FLOT)

A Phase 2 study testing perioperative treatment in people with Gastric Cancer by AJCC V8 Stage and Resectable Carcinoma, run by Centre Francois Baclesse at 13 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Multicenter, open-label, non randomized, phase 2 trial in resectable gastric or gastroesophageal junction adenocarcinoma: Perioperative Treatment by Spartalizumab (PDR001) in Combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
perioperative treatment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
13 sitesFrance
Study dates
28 Jun 2021to 27 Nov 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • 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
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  • Screening laboratory values must meet the following criteria:
  • WBC ≥ 2000/ mm³
  • Neutrophils ≥ 1500/ mm³
  • Platelets ≥ 100 000/ mm³
  • Hemoglobin ≥ 9.0 g/dL
  • Bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3 x ULN
  • Measured or calculated creatinine ≥ 50 ml/min clearance (CrCl) (using the Cockcroft-Gault formula)
  • Potassium ≥ LLN
  • Magnesium ≥ LLN
  • 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
  • Subject affiliated to a social security regimen
  • Patient has signed informed consents obtained before any trial related activities and according to local guidelines

Who cannot join

  • Subject with any distant metastasis
  • Subject with no recovering from the effects of major surgery or significant traumatic injury within 14 days before inclusion
  • 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)
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  • 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 GASPAR Protocol - EUDRACT number: 2020-004497-21 - version 1.3 / 2021-01-18 Page 8 sur 44
  • Known history of HIV or HBV infection
  • 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
  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

France13 sites

  • CHU Besançon

    Besançon

  • Centre François Baclesse

    Caen

  • Centre Georges Francois Leclerc

    Dijon

  • Chru Lille

    Lille

  • APHM Marseille

    Marseille

  • Institut Régional Cancer

    Montpellier

  • APHP St Louis

    Paris

  • Institut Mutualiste Montsouris

    Paris

  • CHU Poitiers

    Poitiers

  • CHU Robert Debré

    Reims

  • Centre Eugène Marquis

    Rennes

  • ICO St Herblain

    Saint-Herblain

  • CH St Malo

    St-Malo

Other trials in France

About this study

Official title: Perioperative Treatment in Resectable Gastric Cancer With Spartalizumab (PDR001) in Combination With Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel (FLOT): A Phase II Study (GASPAR)

Multicenter, open-label, non randomized, phase 2 trial in resectable gastric or gastroesophageal junction adenocarcinoma: Perioperative Treatment by Spartalizumab (PDR001) in Combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT)

Being tested
perioperative treatment
Keywords
perioperative, spartalizumab, PDR001, Gastric Cancer
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • perioperative treatmentDrug

    FLOT + Spartalizumab

Study groups in NCT04736485
Study groupRoleWhat they receive
FLOT regimen plus SpartalizumabExperimentalStandard FLOT regimen * Docetaxel 50 mg/m² IV infusion on D1 * Oxaliplatine 85 mg/m² IV infusion on D1 * Leucovorin 200 mg/m² IV infusion on D1 * Fluorouracile 2600 mg/m² 24 h IV infusion on D1 with Spartalizumab PDR001 Patients will received the fixed dose of 400 mg per IV infusion on D1 every four weeks (q4w) for 2 pre-operative cycles (8 weeks) and 2 post-operative cycles (8 weeks)
Receives: Drug: perioperative treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathologic Response After Pre-operative Treatment

    Proportion of patients with pCR (pathologic complete response) in the primary tumour defined as: no tumour residue found in the tissue collected during the surgery evaluated by the pathologist.

    For the primary objective, the pathologic response after pre-operative treatment will be assessed by the local experienced pathologists. Tumour regression grade will be quantified using the Becker regression criteria, which are based on the estimation of the percentage of vital tumour cells in relation to the macroscopically identifiable tumour bed and include the following categories:

    • TRG1a (equivalent to pathological complete regression; no residual tumour cells);
    • TRG1b (subtotal regression; <10% residual tumour cells);
    • TRG2 (partial regression; 10-50% residual tumour cells); and
    • TRG3 (minor or no regression; >50% residual tumour cells).

    Measured: At surgery, an average 3 months after treatment initiation

Secondary outcomes (4)

  1. Evaluate the Impact of Perioperative Treatment on Disease-free Survival

    Disease-free survival (DFS) defined as time between inclusion and first disease progression. Disease was assessed locally according to RECIST v1.1 (Response Evaluation Criteria in solid Tumors) criteria.

    Measured: 24 months after study enrollment

  2. Evaluate the Impact of Perioperative Treatment on Overall Survival

    Overall survival (OS) defined as the time between inclusion and death whatever cause;

    Measured: 24 months after enrollment

  3. The Correlation Between Pathologic Complete Response and Survival Outcomes (Disease-free and Overall Survival)

    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

    Measured: At surgery, an average 3 months after treatment initiation

  4. Treatment-Related Adverse Events

    Type, grade and number of Adverse Events as Assessed by CTCAE v5.0

    Measured: Toxicities occurring up to 1 month after the end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2021
  2. Study start28 Jun 2021
  3. Primary completion1 Mar 2024
  4. Study completion27 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04736485
Sponsor's protocol ID
2020-004497-21
Acronym
GASPAR
Status last verified
Apr 2026
First submitted
26 Jan 2021
Last updated
8 May 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Dos Santos M, Lequesne J, Piessen G, Leconte A, Guimbaud R, Pernot S, Bouche O, Hiret S, Soularue E, Tougeron D, Dahan L, Le Sourd S, Borg C, Samalin E, Corbinais S, Parzy A, Guilloit JM, Varatharajah S, Brachet PE, Dorbeau M, Galais MP, Desgrippes R, Clarisse B. Perioperative treatment in resectable gastric cancer with spartalizumab in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT): Results from the GASPAR phase 2 study. Eur J Cancer. 2026 Mar 11;236:116258. doi: 10.1016/j.ejca.2026.116258. Epub 2026 Jan 30.

    PubMed 41653501

  • Klute KA, Shah MA. Evolving Therapeutics for Resectable Esophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257044. doi: 10.6004/jnccn.2025.7044.

    PubMed 40340830

  • Dos Santos M, Lequesne J, Leconte A, Corbinais S, Parzy A, Guilloit JM, Varatharajah S, Brachet PE, Dorbeau M, Vaur D, Weiswald LB, Poulain L, Le Gallic C, Castera-Tellier M, Galais MP, Clarisse B. Perioperative treatment in resectable gastric cancer with spartalizumab in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT): a phase II study (GASPAR). BMC Cancer. 2022 May 12;22(1):537. doi: 10.1186/s12885-022-09623-z.

    PubMed 35549674

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing perioperative treatment in people with Gastric Cancer by AJCC V8 Stage and Resectable Carcinoma, run by Centre Francois Baclesse at 13 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic Response After Pre-operative Treatment (time frame: At surgery, an average 3 months after treatment initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04736485, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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