Study of Pembrolizumab, Trastuzumab, and Drug Combination for Patients with HER2-Positive, Localized Esophagogastric Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer called HER2-positive, localized esophagogastric adenocarcinoma. This is a cancer that affects the area where the esophagus meets the stomach and is characterized by an overexpression of a protein known as HER2. The study will explore the effectiveness of a combination of treatments, including pembrolizumab, trastuzumab, and a chemotherapy regimen known as FLOT. Pembrolizumab, also known by its code name MK-3475, is an immunotherapy drug that helps the immune system fight cancer. Trastuzumab, sometimes referred to by code names like PF-05280014, is a targeted therapy that specifically attacks HER2-positive cancer cells. FLOT is a combination of chemotherapy drugs used to treat this type of cancer.

The purpose of the study is to assess how well these treatments work together in preventing the cancer from returning and achieving a complete response, meaning no signs of cancer remain after treatment. Participants in the study will receive these treatments before and after surgery to remove the cancer. The study will monitor the participants’ health and response to the treatment over a period of time, with regular check-ups and assessments to ensure safety and effectiveness.

Throughout the study, participants will receive the treatments through intravenous infusions, which means the medication is delivered directly into the bloodstream through a vein. The study aims to provide valuable information on the potential benefits of combining these treatments for patients with HER2-positive esophagogastric adenocarcinoma, contributing to the development of more effective cancer therapies.

1 joining the trial

Upon joining the trial, you will provide written informed consent, confirming your understanding and agreement to participate in the study.

You will be required to meet specific eligibility criteria, including age, health status, and medical history, to ensure you are suitable for the trial.

2 initial assessment

An initial assessment will be conducted to evaluate your health and confirm the diagnosis of HER2-positive, localized esophagogastric adenocarcinoma.

This assessment may include imaging tests such as CT or MRI scans to ensure the absence of distant metastases and confirm the resectability of the tumor.

3 treatment phase

You will receive a combination of medications administered through intravenous use. These medications include docetaxel, trastuzumab, oxaliplatin, fluorouracil, disodium folinate, and pembrolizumab.

The treatment is designed to be given in cycles, with specific dosages and frequencies determined by the study protocol. The duration of this phase will be outlined by your healthcare provider.

4 surgical treatment

Following the treatment phase, you will undergo surgical treatment to remove the tumor. This step is crucial for achieving potential curative resection.

The surgery will be planned based on the response to the initial treatment and the overall health assessment.

5 post-surgery treatment

After surgery, you will continue to receive the study medications, including pembrolizumab and trastuzumab, to help prevent the recurrence of cancer.

The frequency and duration of this post-surgery treatment will be determined by the study protocol and your healthcare provider.

6 follow-up and monitoring

Regular follow-up appointments will be scheduled to monitor your health and assess the effectiveness of the treatment.

During these visits, any side effects or adverse events will be recorded and managed according to the study guidelines.

Who Can Join the Study?

The participant must provide written informed consent for the trial.
Male participants: Must agree to use contraception during the treatment period and for at least 6 months after the last dose of the study medication. They must also refrain from donating sperm during this time.
Female participants: Must not be pregnant or breastfeeding. They must either not be of childbearing potential or agree to use contraception during the treatment period and for at least 7 months after the last dose of the study medication.
Participants must have adequate organ function, which will be checked with tests done within 14 days before joining the study.
Participants must be at least 18 years old.
The participant must be willing and able to follow the study protocol, including planned surgical treatment.
Participants must have a confirmed diagnosis of adenocarcinoma of the gastroesophageal junction or stomach that is considered resectable (able to be surgically removed) and does not involve distant spread or certain other conditions.
Participants must have HER2-positive disease, which means their cancer cells have more HER2 protein than normal, as confirmed by specific tests.
Participants must be candidates for surgery that aims to cure the cancer.
Participants must not have had any previous systemic anti-cancer therapy, such as chemotherapy or radiotherapy.
Participants must not have had any previous partial or complete removal of the esophagogastric tumor.
Participants must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but do not require bed rest during the day.

Who Cannot Join the Study?

Patients with any other type of cancer that is not HER2-positive, localized esophagogastric adenocarcinoma cannot participate. HER2-positive means that the cancer has a protein that promotes the growth of cancer cells.
Patients who have had any other cancer treatment in the past that might interfere with the study cannot participate.
Patients with serious heart problems cannot participate.
Patients with uncontrolled infections cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are unable to follow the study procedures cannot participate.
Patients with any other medical condition that the study doctors think might make it unsafe for them to participate cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Haematologisch Onkologische Praxis Eppendorf	Hamburg	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Klinikum Nuernberg	Nürnberg	Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH	Regensburg	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Sbb Akmr Hujpdiqc	Herne	Germany
Pndoornz Wnqohxpxm	Wolfsburg	Germany
Knzzzjie Eqxxwwvygdbtnjnuwxafbcss Hfodfckacjlnmlacc	Essen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.07.2022

Trial locations

Investigated drugs:

Pembrolizumab is a type of immunotherapy medication. It works by helping your immune system recognize and attack cancer cells. In this trial, it is used to help treat esophagogastric adenocarcinoma, a type of cancer that affects the stomach and esophagus.

Trastuzumab is a targeted therapy used to treat cancers that have a high amount of a protein called HER2. It works by attaching to the HER2 protein on cancer cells, which can help slow or stop the growth of the cancer. In this trial, it is used in combination with other treatments to target HER2-positive cancer cells.

FLOT is a combination of chemotherapy drugs used to treat certain types of cancer, including esophagogastric adenocarcinoma. The FLOT regimen includes four different medications that work together to kill cancer cells and stop them from growing. In this trial, FLOT is used as part of the treatment plan to help improve outcomes for patients with this type of cancer.

Investigated diseases:

HER2-positive localized esophagogastric adenocarcinoma – This is a type of cancer that occurs in the esophagus or stomach and is characterized by the overexpression of the HER2 protein. It begins in the glandular cells lining the esophagus or stomach, which produce mucus and other fluids. As the disease progresses, the cancer cells can grow and invade deeper layers of the esophagus or stomach wall. The cancer may spread to nearby lymph nodes and, in advanced stages, to other parts of the body. The progression of the disease can lead to symptoms such as difficulty swallowing, weight loss, and abdominal pain. The rate of progression can vary depending on various factors, including the specific characteristics of the tumor and the overall health of the individual.

Trial ID:

2024-513610-34-00

Protocol code:

PHERFLOT

NCT ID:

NCT05504720

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Pembrolizumab, Trastuzumab, and Drug Combination for Patients with HER2-Positive, Localized Esophagogastric Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?