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Study of HLX22, Trastuzumab, and Chemotherapy for Patients with Advanced or Metastatic Stomach and Gastroesophageal Cancer

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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 treatments for locally advanced or metastatic gastroesophageal junction and gastric cancer. The study will explore the effectiveness of a new treatment combination involving HLX22, which is a recombinant humanized anti-HER2 monoclonal antibody injection. This treatment will be combined with trastuzumab and a type of chemotherapy known as XELOX. The study will compare this combination to the standard treatment of trastuzumab and XELOX, with or without the addition of pembrolizumab, which is a solution for infusion.

The purpose of the study is to evaluate how well the new combination works as a first-line treatment for patients with this type of cancer. Participants in the study will be randomly assigned to receive either the new combination or the standard treatment. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving which treatment. This helps ensure the results are unbiased. The study will take place over a period of time, with regular assessments to monitor the progress and health of the participants.

Throughout the study, researchers will focus on key outcomes such as progression-free survival, which measures how long patients live without the cancer getting worse, and overall survival, which measures how long patients live overall. The study will also look at the safety of the treatments and any side effects that may occur. By the end of the study, the goal is to determine if the new treatment combination offers a better option for patients with this type of cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to sign an informed consent form. This form confirms that you understand the study and agree to participate voluntarily.

    You will need to confirm that you meet the study's eligibility criteria, such as having a confirmed diagnosis of locally advanced or metastatic gastroesophageal junction and gastric cancer and being at least 18 years old.

  2. Step 2

    Initial assessments

    Before starting the treatment, several assessments will be conducted to ensure you are eligible. These include blood tests to check for HIV, hepatitis B, and hepatitis C, as well as a pregnancy test for women of childbearing potential.

    Your organ function will be evaluated, and you will need to have a measurable disease as assessed by specific criteria.

  3. Step 3

    Treatment phase

    You will be randomly assigned to one of the treatment groups. The treatments involve a combination of medications administered intravenously (through a vein).

    One group will receive **HLX22** (a humanized antibody) in combination with **trastuzumab** and chemotherapy (XELOX), while another group will receive **trastuzumab** and chemotherapy (XELOX) with or without **pembrolizumab**.

    The specific dosage and frequency of administration will be determined by the study protocol and your healthcare team.

  4. Step 4

    Ongoing assessments

    Throughout the study, regular assessments will be conducted to monitor your health and the effectiveness of the treatment. This includes evaluating progression-free survival and overall survival.

    You will also be monitored for any adverse events or side effects related to the treatment.

  5. Step 5

    End of treatment

    At the end of the treatment period, final assessments will be conducted to evaluate the overall response to the treatment.

    You may be asked to continue follow-up visits to monitor your health and any long-term effects of the treatment.

Who can join the trial?

12 criteria

  • Voluntary participation: You must fully understand the study, be informed about it, and sign a consent form to show you agree to participate.
  • HIV status: You must test negative for HIV antibodies. If you test positive, you need to have been on antiretroviral therapy for at least four weeks and have a low HIV viral load (less than 400 copies/mL) before joining the study.
  • Adequate organ function: Your organs must be working well enough as defined by the study guidelines.
  • Pregnancy and contraception: If you are a woman who can have children, you must have a negative pregnancy test within 7 days before starting the study. Both women who can have children and men with partners who can have children must use at least one highly effective birth control method during the study and for at least nine months after the last dose of study treatment.
  • Age requirement: You must be at least 18 years old on the day you sign the consent form.
  • Diagnosis: You must have a confirmed diagnosis of previously untreated, locally advanced, unresectable, or metastatic **HER2-positive** gastric or gastroesophageal junction adenocarcinoma. **HER2-positive** means your tumor has a specific protein that can be targeted by certain treatments.
  • Measurable disease: You must have a tumor that can be measured according to specific criteria, and it must not be only in the bones.
  • **HER2-positive** tumor: Your tumor must be confirmed as **HER2-positive** by a central laboratory using specific tests.
  • Performance status: You must have an **ECOG PS** (Eastern Cooperative Oncology Group Performance Status) of 0-1 within 7 days before starting the study. This is a scale that measures how well you can perform daily activities.
  • Expected survival: You must be expected to live for at least 6 months.
  • Hepatitis B status: You must test negative for Hepatitis B surface antigen and core antibody. If you test positive, your Hepatitis B virus DNA must be below a certain level or within the normal range.
  • Hepatitis C status: You must test negative for Hepatitis C antibodies. If you test positive, further testing must show no active infection. You cannot participate if you have both Hepatitis B and C.

Who cannot join the trial?

7 criteria

  • Patients with other types of cancer that are not locally advanced or metastatic gastroesophageal junction and gastric cancer cannot participate. Locally advanced means the cancer has spread to nearby areas, and metastatic means it has spread to other parts of the body.
  • Patients who have received certain treatments for cancer before may not be eligible.
  • Patients with serious heart conditions or other severe health issues might be excluded.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who are unable to follow the study procedures or attend the required visits may not be eligible.
  • Patients with known allergies to the study drugs or similar medications cannot participate.
  • Patients who are participating in another clinical trial at the same time may be excluded.
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Investigated drugs

  • HLX22

    is a type of medication known as a monoclonal antibody. It is designed to target and attach to a specific protein called HER2, which is found on the surface of some cancer cells. By attaching to this protein, HLX22 can help the body's immune system recognize and attack the cancer cells. In this clinical trial, HLX22 is being tested to see if it can help treat certain types of stomach cancer when used together with other cancer treatments.

  • Trastuzumab

    is another monoclonal antibody that targets the HER2 protein on cancer cells. It works by blocking the signals that tell cancer cells to grow and divide. Trastuzumab is often used to treat cancers that have high levels of HER2, such as some breast and stomach cancers. In this study, it is being used in combination with other treatments to see if it can improve outcomes for patients with advanced stomach cancer.

  • Pembrolizumab

    is a type of medication known as an immune checkpoint inhibitor. It helps the immune system recognize and attack cancer cells by blocking a specific protein that prevents the immune system from working properly. This can help the body fight cancer more effectively. In this trial, pembrolizumab is being tested to see if it can enhance the effects of other cancer treatments for patients with advanced stomach cancer.

  • XELOX

    is a combination of two chemotherapy drugs, capecitabine and oxaliplatin. Chemotherapy works by killing fast-growing cells, including cancer cells. Capecitabine is a drug that is taken by mouth and turns into a substance that attacks cancer cells. Oxaliplatin is given through an IV and works by damaging the DNA of cancer cells, which stops them from growing and dividing. Together, these drugs are used to treat various types of cancer, including stomach cancer, by slowing or stopping the growth of cancer cells.

What is already known about the treatment

HLX22 – HLX22 is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating advanced stages of gastroesophageal junction and gastric cancer. It is a humanized monoclonal antibody that targets the HER2 protein, which is often overexpressed in certain types of cancer cells, helping the immune system to recognize and destroy these cells. This medication is part of a class of drugs known as monoclonal antibodies, which are designed to specifically target and bind to proteins on cancer cells.

Investigated diseases

Locally advanced/metastatic gastroesophageal junction and gastric cancer – This disease involves the abnormal growth of cells in the stomach and the area where the esophagus meets the stomach, known as the gastroesophageal junction. In its locally advanced stage, the cancer has spread beyond the stomach lining to nearby tissues or lymph nodes but not to distant body parts. When it becomes metastatic, the cancer cells have spread to other parts of the body, such as the liver, lungs, or distant lymph nodes. The progression of this cancer can lead to symptoms like difficulty swallowing, weight loss, and stomach pain. As the disease advances, it may cause more severe symptoms due to the spread of cancer cells to other organs. The progression is typically monitored through imaging and clinical evaluations to assess the extent of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516633-12-00Protocol codeHLX22-GC-301Estimated enrolment550 patientsSponsorShanghai Henlius Biotech Inc.

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