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Study of Sacituzumab Govitecan for Patients with Advanced Esophagogastric Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

10 criteria

  • 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.
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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.

What is already known about the treatment

Sacituzumab Govitecan – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic esophagogastric adenocarcinoma, a type of advanced stomach cancer. It is a targeted therapy that combines an antibody with a chemotherapy drug, specifically designed to attach to a protein called TROP-2 found on cancer cells. Once attached, it delivers the chemotherapy directly to the cancer cells, helping to destroy them. Sacituzumab Govitecan is classified as an antibody-drug conjugate, and its use is being explored to provide a new treatment option for patients with this aggressive cancer.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-505257-40-00Protocol codeSAGAEstimated enrolment67 patientsSponsorInstitut fuer Klinische Krebsforschung IKF GmbH

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