Neoplasms

Digestive System Diseases

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Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

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Anti-Infective Agents

Capecitabine

Docetaxel

Epirubicin

Oxaliplatin

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Antimetabolites

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Patients will receive cycles every 3 weeks of Docetaxel (35 mg/ m2, intravenous at days 1 and 8 by 1-hour infusion)and Oxaliplatin (80 mg/ m2, intravenous at day 1 by 2-hour infusion) and Capecitabine (750 mg/ m2, oral tablets of 500 and 150 mg, x2 daily for 2 weeks)

Patients will receive cycles every 3 weeks of Epirubicin (50 mg/ m2, intravenous on day 1 by 2-hour infusion)and Oxaliplatin (130 mg/ m2, intravenous on day 1 by 2-hour infusion) and Capecitabine (625 mg/ m2,oral tablets of 500 and 150 mg, x2 daily for 3 weeks)

Roberto Labianca, MD

Enrico Cortesi, MD

Domenico Cristiano Corsi, MD

Pietro Sozzi, MD

Luigi Cavanna, MD

Domenico Bilancia, MD

Rosa Rita Silva, MD

Nicola Fazio, MD

Monica Giordano, MD

Alessandro Bertolini, MD

Giovanni Ucci, MD

Donato Natale, MD

Daris Ferrari, MD

Graziella Pinotti, MD

Ermanno Rondini, MD

Massimo Cirillo, MD

Rosario Vincenzo Iaffaioli, MD

Andrea Ciarlo, MD

Elena Piazza, MD

Libero Ciuffreda, MD

Stefania Dell'Oro, MD

Fabrizio Artioli, MD

Claudio Verusio, MD

Vincenzo Catalano, MD

Claudio Graiff, MD

Domenico Amoroso, MD

Maria Di Bartolomeo, MD

Nicola Silvestris, MD

Maria C. Zavettieri, MD

Enzo Veltri, MD

Francesco Ferraù, MD

Giampaolo Tortora, MD

Sandro Barni, MD

Mario Scartozzi, MD

This is a randomized, parallel group, non-blinded phase III trial. Patients with advanced (locoregional or metastatic) gastric cancer not previously treated with chemotherapy for this stage will be randomized in a 1:1 ratio to receive low-TOX (arm A) or EOX (arm B). Randomization will be stratified by performance status (ECOG 0, 1 and 2).

Although the incidence of the adenocarcinoma of the stomach is slowly decreasing, gastric cancer represents the second worldwide cause of cancer death after lung cancer. In patients with advanced disease, chemotherapy improves survival and quality of life. Combinations of two or three drugs including a platin derivative (cisplatin or oxaliplatin), a fluoropyrimidine (5FU or capecitabine) and an anthracycline (usually epirubicin) have demonstrated superiority compared to single or double agent therapy and are the current standard. As of today there are no published studies comparing anthracycline-based to taxane-based three-drug regimens. The objective of the present study is to compare EOX as evaluated in REAL-2 to the low-TOX regimen consisting of docetaxel, oxaliplatin and capecitabine. Low-TOX is expected to be better tolerated than the original DCF regimen. The study will be performed in the HER2 negative patients.

Low-Tox Vs Eox In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer

A Randomized Phase III Study Of Low-Docetaxel Oxaliplatin, Capecitabine (Low-Tox) Vs Epirubicin, Oxaliplatin And Capecitabine (Eox) In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer

To determine the progression free survival (PFS) of patients with locally advanced unresectable or metastatic gastric cancer treated with Docetaxel plus Oxaliplatin plus Capecitabine (Arm A) or with Epirubicin plus Oxaliplatin plus Capecitabine (Arm B)

To assess overall survival (OS) of patients with locally advanced unresectable or metastatic gastric cancer treated with Docetaxel plus Oxaliplatin plus Capecitabine (Arm A) or with Epirubicin plus Oxaliplatin plus Capecitabine (Arm B)

To assess objective response rate (CR+PR)of patients with locally advanced unresectable or metastatic gastric cancer treated with Docetaxel plus Oxaliplatin plus Capecitabine (Arm A) or with Epirubicin plus Oxaliplatin plus Capecitabine (Arm B)

To assess disease control rate of patients with locally advanced unresectable or metastatic gastric cancer treated with Docetaxel plus Oxaliplatin plus Capecitabine (Arm A) or with Epirubicin plus Oxaliplatin plus Capecitabine (Arm B)

To assess tolerability of the treatments of patients with locally advanced unresectable or metastatic gastric cancer treated with Docetaxel plus Oxaliplatin plus Capecitabine (Arm A) or with Epirubicin plus Oxaliplatin plus Capecitabine (Arm B)

Regione Lombardia

Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

Pemigatinib,13.5mg ,QD,po, 2 weeks / 1 week;Q 3W

Pemigatinib

purpose of research： fundamental purpose:

• To evaluate the effectiveness of pemitinib in patients with advanced gastric cancer who have failed standard therapy with fibroblast growth factor receptor 1-3 (FGFR1-3) variant (including but not limited to FGFR1-3 amplification, rearrangement / fusion, mutation, etc.).

Secondary purpose:

* To evaluate the safety and tolerability of pemitinib in patients with advanced gastric cancer who have previously failed standard therapy with the FGFR1-3 variant: including incidence of adverse events (AEs) and serious adverse events (SAEs) and association with therapy. Incidence of treatment-related AEs / SAEs.
* Exploring efficacy and safety in subjects with different FGFR variant types.

The end of the study:

Main end point:

• The primary endpoint of the study was the 6-month PFS rate (progression-free survival, defined as first dose to disease progression \[PD\] or death).

Secondary end point:

• Objective response rate (defined as the proportion of subjects achieving complete response (CR) or partial response (PR) by RECIST1.1 criteria).

Duration of response (DOR, defined as the time from first CR or PR to PD, is used only for subjects with an objective response).

* Disease control rate (DCR, defined as the proportion of subjects with CR + PR + stable disease stable \[SD\]).
* Overall survival (OS, defined as the time of first dose to death from any cause).
* Safety and tolerability: Grade evaluation for assessing the severity of adverse events according to NCI CTCAE (version 5.0), including:

  1. Incidence, severity, and association of all AEs, TRAEs, SAEs, and the study drug;
  2. Number and proportion of subjects stopping treatment due to the above adverse events;
  3. Study changes in vital signs, physical examination findings, and laboratory results before, during and after treatment.
* To describe the efficacy and safety in subjects with different FGFR gene variant types.

research design: This study is a prospective, single-arm, phase II clinical study. Patients with advanced gastric cancer who had failed standard treatment with FGFR1-3 variant, were included in the study by meeting the inclusion criteria after completing the informed consent. Patients will receive pemitinib 13.5 mg once daily (QD) orally on a 2-week dose / 1-week withdrawal regimen. Subjects will continue treatment until disease progression or intolerable toxicity. Clinical tumor imaging evaluation per RECIST v1.1, every 6 weeks (± 7 days) and every 9 weeks (± 7 days) after 48 weeks. Safety assessment was performed using NCI-CTCAE 5.0.

Pemitinib, dose and mode of administration:

Pemitinib will be treated as a 2 week / 1 week withdrawal regimen, 1 dose, 13.5mg, QD, 21 day cycle. Subjects should be on pometitinib at a fixed time per day to avoid inconsistent effects on plasma concentration.

Sample size and statistical methods:

1. In this study, using the 6-month PFS rate as the primary endpoint, Calculted using the confidence interval method of Kapian-Meier estimation, Based on the historical data, The 6-month PFS rate of second-line chemotherapy in subjects with previous first-line treatment was approximately 20% (RAINBOW study, BRIGHTER Study), The 6-month PFS rate in subjects with previous second-line or more treatment was approximately 10% (Attraction-2 study), It is estimated that about 20% of the second-line and above treated subjects will be included in this study, The overall 6-month PFS rate was about 18%, Assuming that the 6-month PFS rate could be improved to 36%, Using the test level as one-sided α =0.1, ß=0.20, After follow-up for at least 6 months, With 80% confidence be observed with a 90% confidence interval lower bound greater than 18%, In total, 23 subjects will need to be enrolled.
2. Statistical analysis method: Continuous variables were described by mean, standard deviation, median, minimum and maximum values, and categorical variables were described by frequency and percentage. The proportion of subjects with the ORR and DCR and their 95% CI were estimated. Median PFS, DOR, and OS were estimated using Kaplan-Meier.

A Single Arm, Phase II Exploratory Clinical Study of Pemitinib in Advanced Gastric Cancer With Previous Standard Therapy Failure the FGFR Variant

A Single Arm, Phase ll Exploratory Clinical Study of Pemetinib in the Treatment of Advanced Gastric Cancer With FGFR Mutation and Previous Standard Treatment Failure

to evaluate the efficacy of pemitinib in patients with advanced gastric cancer who have previously failed standard therapy with FGFR1-3 variants

Sun Yat-sen University

chief physician

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Low-Tox Vs Eox In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer	NCT02076594	Locally Advance... Metastatic Gast...	Docetaxel Epirubicin Oxaliplatin Capecitabine	18 Years -	Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
A Single Arm, Phase II Exploratory Clinical Study of Pemitinib in Advanced Gastric Cancer With Previous Standard Therapy Failure the FGFR Variant	NCT05997459	Locally Advance...	Pemigatinib	18 Years -	Sun Yat-sen University

Spots Global Cancer Trial Database for locally advanced unresectable gastric cancer