Trials Sponsors Conditions Drugs Pricing

Conditions

Gastric Cancer by AJCC V8 Stage Resectable Carcinoma

Keywords

perioperativespartalizumabPDR001Gastric Cancer

Outcome Measures

Primary Outcomes (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).
At surgery, an average 3 months after treatment initiation

Secondary Outcomes (4)

Evaluate the Impact of Perioperative Treatment on Disease-free Survival
24 months after study enrollment
Evaluate the Impact of Perioperative Treatment on Overall Survival
24 months after enrollment
The Correlation Between Pathologic Complete Response and Survival Outcomes (Disease-free and Overall Survival)
At surgery, an average 3 months after treatment initiation
Treatment-Related Adverse Events
Toxicities occurring up to 1 month after the end of treatment

Study Arms (1)

FLOT regimen plus Spartalizumab

EXPERIMENTAL

Standard 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)

Drug: perioperative treatment

Interventions

perioperative treatmentDrug

FLOT + Spartalizumab

FLOT regimen plus Spartalizumab

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥ 18 years
Untreated localized gastric or GEJ adenocarcinoma considered resectable (clinical stage ≥cT2 and/or cN+ and no metastasis)

Sponsors & Collaborators

Centre Francois Baclesse
Otherlead
National Cancer Institute, France
Governmentcollaborator

Study Sites (13)

CHU Besançon

Besançon, France

Centre François Baclesse

Caen, France

Centre Georges Francois Leclerc

Dijon, France

Chru Lille

Lille, France

APHM Marseille

Marseille, France

Institut Régional Cancer

Montpellier, France

APHP St Louis

Paris, France

Institut Mutualiste Montsouris

Related Publications (3)

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.
PMID: 41653501RESULT
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.
PMID: 40340830DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Results Point of Contact

Title: Justine Lequesne
Organization: Centre François Baclesse

Publication Agreements

PI is Sponsor Employee: Yes
Restrictive Agreement: No

Enrollment

67 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 3, 2021

Study Start

June 28, 2021

Actual (reported)

Primary Completion

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

FLOT regimen plus Spartalizumab

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

FLOT regimen plus Spartalizumab

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations