Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Oxaliplatin

Fluorouracil

FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel

FLOT Regimen

FLO Regimen: 5-fluorouracil, Oxaliplatin FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel

FLO Regimen or FLOT Regimen

Baorui Liu, MD, PHD

Jia Wei, MD, PHD

Evaluation of customized treatment according to BRCA1 assessment in patients with advanced gastric cancer

Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Baorui Liu

Adenocarcinoma

Micronutrients

Amino Acids

Leucovorin

Capecitabine

Immunomodulating Agents

Taurine

Taurine + Serplulimab + XELOX or Taurine + Serplulimab + FLOT

Serplulimab + XELOX or Serplulimab + FLOT

Taurine supplementation in capsules of 1.0 gram of taurine powder. Dosage: 2.0 gram/day. Frequency: 2 time/day.

Serplulimab

XELOX regimen

Fluorouracil + leucovorin + oxaliplatin + docetaxel

FLOT regimen

Xiaodi Zhao, MD, PhD

Xin Wang, MD, PhD

Jia Yu, MD

Yuanyuan Lu, MD, PhD

This project aims to evaluate the efficacy and safety of oral taurine supplementation combined with PD-1 inhibitor (serplulimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with serplulimab and chemotherapy alone.

Prospective, randomized controlled clinical study

Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer

A Prospective, Randomized Controlled Clinical Study of The Efficacy and Safety of Taurine Combined With Serplulimab and Chemotherapy Versus Serplulimab Combined With Chemotherapy for Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

To evaluate the pathologic complete response rate of locally advanced gastric cancer treated with concurrent serplulimab with chemotherapy with or without taurine supplementation.

The surgical margin is microscopically-negative for residual tumor.

Residual tumor cells below 10% in the resected specimen.

DFS was defined as the time from surgery to postoperative recurrence or death from any cause, whichever occurred first. DFS was censored on the last tumor assessment date for patients still alive and without recurrence.

EFS was the time from enrollment to recurrence or death from any cause. EFS was censored on the last tumor assessment date for patients still alive and without recurrence.

OS was the time from enrolment to death from any cause. OS was censored on the last date known to be alive for patients without documentation of death.

Changes in number, effector (TNF-α, IFN-γ, etc.) production and immune checkpoint molecule (PD-1, CTLA-4, etc.) expression of tumor-infiltrating CD8+ T cells in gastric cancer endoscopic biopsy or surgical resection material assessed via flow cytometry and immunohistochemistry.

Changes in number, apoptosis rate, effector (TNF-α, IFN-γ, etc.) production and immune checkpoint molecule (PD-1, CTLA-4, etc.) expression of CD8+ T cells in peripheral venous blood assessed via flow cytometry.

Number of study subjects experiencing adverse events (AEs), dose-limiting toxicities, and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.

Tang-Du Hospital

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Dexamethasone acetate

Mitogens

FLOT Chemotherapy regimen

A cycle consist of Day 1: 5-fluorouracil (5-FU) 2600mg/M2 intravenous Via peripherally inserted central catheter (PICC) for 24 hour Day 1: Leucovorin 200mg/M2 intravenous Day 1: Oxaliplatin 85mg/ M2 intravenous Day 1: Docetaxel 50mg/M2 intravenous Repeated every 15th day

Patients will receive four cycles of the standard dose of FLOT chemotherapy prior to curative gastrectomy. And four cycles of the FLOT chemotherapy is recommended after surgery. Preventive antiemetic and dexamethasone are allowed before chemotherapy, growth factor, or other supportive medicines are allowed for treatment only. Surgical intervention is allowed for acute bleeding or other surgical emergencies.

Chemotherapy

Birendra K Sah, PH D

Chen Li, PH D

Zhenggang Zhu, PH D

Neoadjuvant chemotherapy for advanced-stage gastric cancer is justified by various studies, however, there was not any large scale randomized controlled trial (RCT) to support it until German oncologist introduced a novel regimen(FLOT regimen) in 2017. Investigator assessed the FLOT regimen for safety and feasibility in Chinese gastric cancer patients.

Neoadjuvant chemotherapy for advanced-stage gastric cancer is justified by various studies, however, there was not any large scale RCT to support it until German oncologist introduced a novel regimen(FLOT regimen) in 2017. FLOT regimen was prescribed for German patients and various questions are raised by experts from Eastern countries. As the FLOT regimen was officially included in NCCN 2018 guidelines, the investigator used standard protocol of FLOT regimen on Chinese gastric cancer patients. Safety and feasibility were assessed carefully to provide basic data for further large scale studies in China.

Feasibility and Safety of Neoadjuvant Chemotherapy (FLOT ) for Gastric Cancer Patients in China

Pilot Study on Feasibility and Safety of FLOT Regimen as Neoadjuvant Chemotherapy in Chinese Gastric Cancer Patients

How many patients completed the plan preoperative chemotherapy regimen

Chemotherapy related adverse events according to the CTCAE version 3.0

According to tumor regression grading(TRG)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer	NCT01206218	Advanced Gastri...	FLOT Regimen FLO Regimen or ...	18 Years -	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer	NCT06128252	Gastric Cancer	Taurine Serplulimab XELOX regimen FLOT regimen	18 Years - 75 Years	Tang-Du Hospital
Feasibility and Safety of Neoadjuvant Chemotherapy (FLOT ) for Gastric Cancer Patients in China	NCT03646591	Chemotherapy Ef...	Chemotherapy	18 Years - 80 Years	Ruijin Hospital

Spots Global Cancer Trial Database for flot regimen

Every month we try and update this database with for flot regimen cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.