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Study of Sacituzumab Govitecan for Patients with Advanced Esophagogastric Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer called metastatic esophagogastric adenocarcinoma, which is a stage IV cancer affecting the esophagus and stomach. The treatment being tested is a medication known as sacituzumab govitecan. This medication is a special type of drug that targets a protein called TROP-2, which is found on the surface of some cancer cells. Sacituzumab govitecan is designed to deliver a cancer-fighting substance directly to these cells.

The purpose of this study is to evaluate how effective sacituzumab govitecan is for patients with metastatic esophagogastric adenocarcinoma. Participants in the study will receive the medication through an intravenous infusion, which means it will be administered directly into a vein. The study will follow a single-arm design, meaning all participants will receive the same treatment without a comparison group. Some participants may receive a placebo, which is a substance with no active medication, to help researchers understand the effects of the treatment.

Throughout the study, researchers will monitor participants to assess their response to the treatment. This includes looking at the overall response rate, which measures how well the cancer responds to the medication. The study aims to provide valuable information about the potential benefits of sacituzumab govitecan for treating this type of cancer. Participants will be closely observed by medical professionals to ensure their safety and to gather important data about the treatment’s effectiveness.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

Eligibility criteria include being 18 years or older, having a confirmed diagnosis of metastatic esophagogastric adenocarcinoma, and having received prior therapy with specific medications.

2 treatment initiation

The treatment involves the administration of sacituzumab govitecan, which is given through an intravenous infusion.

The dosage and frequency of administration are determined by the study protocol and the healthcare team overseeing the trial.

3 treatment period

During the treatment period, regular monitoring is conducted to assess the response to the medication and to manage any side effects.

Patients are required to attend scheduled visits for evaluations, which may include blood tests and imaging studies.

4 follow-up

After completing the treatment, follow-up assessments are conducted to evaluate the overall response rate, which includes measuring complete and partial responses to the treatment.

The follow-up period is designed to monitor the patient’s health and any long-term effects of the treatment.

Who Can Join the Study?

  • The patient must have given written informed consent, which means they agree to participate in the study after being informed about it.
  • Female patients who can have children and male patients with female partners who can have children must agree to avoid pregnancy. This can be done by not having sexual intercourse or using very effective birth control methods during the study and for at least 6 months after the last treatment. Male patients should not donate sperm during this time. If a male patient has a pregnant partner, he must agree to avoid sexual intercourse or use a condom during the pregnancy.
  • The patient must be willing and able to follow the study rules, according to the doctor’s judgment.
  • The patient must be 18 years of age or older when they sign the consent form.
  • The patient must have been diagnosed with metastatic esophagogastric adenocarcinoma, which is a type of cancer that has spread to other parts of the body.
  • The patient must have received a previous treatment that included a platinum compound and a fluoropyrimidine for their cancer. If they had this treatment before surgery or after surgery and the cancer got worse within 6 months, it counts as the first treatment.
  • The patient must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • The patient must have a life expectancy of at least 12 weeks, meaning they are expected to live for at least 3 months.
  • The patient must have good blood, liver, and kidney function, as shown by specific medical tests. These include having enough white blood cells, platelets, and red blood cells, normal levels of bilirubin, liver enzymes, and kidney function tests, and a stable blood clotting status if not on blood thinners.
  • The patient must be willing to provide blood samples for research purposes.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Haematologisch Onkologische Praxis Eppendorf Hamburg Germany
Medical University Of Vienna Vienna Austria
University Hospital Jena KöR Jena Germany
Universitaet Leipzig Leipzig Germany

Other Sites

Site Name City Country Status
SCRI CCCIT Ges.m.b.H. Salzburg Austria
Krankenhaus Nordwest GmbH Frankfurt Germany
Klinikum Chemnitz gGmbH Chemnitz Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Heidelberg University Mannheim Germany
Klinikum St Marien Amberg Amberg Germany
Onkopraxis Probstheida Leipzig Germany
Uobdoifpnp Mflncgq Cbvvjn Hbzybpydksrgdskgh Hamburg Germany
Kmdbuv Dbo Hdroure Gnjd Stade Germany
Kntvudym Elaofukoawiknxvfjznvlvpu Hfimiqcoxmczxxnqe Essen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.09.2023
Germany Germany
Not recruiting
01.09.2023

Trial locations

Investigated drugs:

Sacituzumab-govitecan is a medication being studied for its effectiveness in treating metastatic esophagogastric adenocarcinoma. It is a type of therapy that combines an antibody targeting a protein called TROP-2 with a chemotherapy drug known as SN38. The antibody helps deliver the chemotherapy directly to the cancer cells, potentially improving the treatment’s effectiveness while reducing side effects on healthy cells.

Investigated diseases:

Metastatic Esophagogastric Adenocarcinoma – This is a type of cancer that originates in the glandular cells of the esophagus or stomach and has spread to other parts of the body, classified as Stage IV. The disease begins in the lining of the esophagus or stomach and can invade nearby tissues. As it progresses, cancer cells travel through the bloodstream or lymphatic system to distant organs, such as the liver or lungs. Symptoms may include difficulty swallowing, weight loss, and abdominal pain. The spread of cancer to other organs can lead to additional symptoms depending on the affected areas. The progression of the disease can vary, with some patients experiencing rapid advancement while others may have a slower course.

Trial ID:
2023-505257-40-00
Protocol code:
SAGA
NCT ID:
NCT06123468
Trial Phase:
Human Pharmacology (Phase I) – Other

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