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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04736485
Other study ID # 2020-004497-21
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date June 28, 2021
Est. completion date March 2027

Study information

Verified date December 2022
Source Centre Francois Baclesse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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)


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Study Design


Intervention

Drug:
perioperative treatment
FLOT + Spartalizumab

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Sponsors (2)

Lead Sponsor Collaborator
Centre Francois Baclesse National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 At surgery, an average 3 months after treatment initiation
Secondary Evaluate the impact of perioperative treatment on disease-free survival Disease-free survival (DFS) defined as time between inclusion and first disease progression Through study completion, an average of 5 follow-up year
Secondary Evaluate the impact of perioperative treatment on overall survival Overall survival (OS) defined as the time between inclusion and death whatever cause; Up to death
Secondary 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 At surgery, an average 3 months after treatment initiation
Secondary Treatment-Related Adverse Events Type, grade and number of Adverse Events as Assessed by CTCAE v5.0 Toxicities occurring up to 1 month after the end of treatment
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