Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Docetaxel

Oxaliplatin

Leucovorin

Fluorouracil

Spartalizumab

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)

perioperative treatment

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)

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

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

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

Disease-free survival (DFS) defined as time between inclusion and first disease progression

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

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

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

National Cancer Institute, France

Centre Francois Baclesse

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Immunomodulating Agents

Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will receive a later-line therapy.

Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will continued their current therapy.

Another chemotherapy regimen, targeted therapy, or immunotherapy

Later-line therapy

Chunmei Bai, MD

Chunmei Bai, M.D.

The goal of this clinical trial is to explore the value of molecular residual disease (MRD) monitoring based on ctDNA in resected pancreatic cancer. The main questions it aims to answer are:

* prognostic value of baseline MRD;
* the role of MRD dynamic changes after treatment in guiding treatment. Peripheral blood derived from participants will be obtained for MRD test before adjuvant chemotherapy initiation and at the first imaging assessment after chemotherapy.

The Value of Molecular Residual Disease Monitoring Based on ctDNA in Resected Pancreatic Cancer

The prognostic value of baseline MRD and dynamic MRD changes

The prognostic role of targeted therapy selected based on MRD

The date of adjuvant chemotherpay initiation to tumor recurrence, local-regional or distant metastases, or death due to any cause.

The date of adjuvant chemotherpay initiation to death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Perioperative Treatment in Resectable Gastric Cancer With Spartalizumab (PDR001) in Combination With Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel (FLOT)	NCT04736485	Gastric Cancer ... Resectable Carc...	perioperative t...	18 Years -	Centre Francois Baclesse
The Value of Molecular Residual Disease Monitoring Based on ctDNA in Resected Pancreatic Cancer	NCT05802407	Pancreatic Canc... Resectable Carc...	Later-line ther...	18 Years -	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for resectable carcinoma