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RecruitingPHASE3INTERVENTIONAL

A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer

This research study is for people who have been recently diagnosed with advanced stomach cancer or cancer where the food pipe meets the stomach. Specifically, it's for cancer that is 'HER2-positive', which means it has a specific protein on the cancer cells. The study is testing a new medicine called HLX22. It will be given along with trastuzumab and chemotherapy, which are common treatments. Some people will get HLX22, while others will get a dummy medicine, in addition to the standard treatments. The main goal is to find out if adding HLX22 helps patients live longer and if it's safe. It's a large study, comparing these treatments to see which is better.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Shanghai Henlius Biotech
Enrolment target
550
Start
22 Nov 2024
Estimated completion
01 Sep 2028

What is this study about?

This study is looking into a new treatment for stomach cancer and cancer of the gastroesophageal junction. The gastroesophageal junction is the area where your food pipe (oesophagus) joins your stomach. This particular study focuses on cancers that are 'HER2-positive'. This means the cancer cells have a lot of a protein called HER2 on their surface. Knowing if a cancer is HER2-positive helps doctors choose the right treatments.

The study is testing a new drug called HLX22 alongside treatments that are already commonly used. These include trastuzumab, which is a 'monoclonal antibody' that targets HER2, and chemotherapy drugs like oxaliplatin and capecitabine. The doctors want to find out if adding HLX22 to these standard treatments can improve how well patients respond and how long they live, as well as checking for any side effects.

This is a 'Phase 3' study, which means it's a large study comparing the new treatment against the best available standard care. Participants will be randomly put into one of two groups: one receiving HLX22 plus standard treatments, and the other receiving a dummy medicine (placebo) plus standard treatments. This approach helps researchers fairly compare the effects of HLX22.

Key takeaways

  • New study for HER2-positive stomach or food pipe cancer.
  • Investigating a new drug (HLX22) combined with standard treatments.
  • Aims to improve treatment effectiveness and safety.
  • Participants are randomly assigned to treatment or control groups.
  • Close medical monitoring throughout the study.
  • Participation is voluntary and you can withdraw anytime.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have advanced HER2-positive stomach cancer or cancer of the gastroesophageal junction that hasn't been treated yet. Doctors need to be able to measure your cancer on scans, and a lab test must confirm that your cancer is HER2-positive.

You would not be able to join if you have had certain other cancers recently, or if your cancer has come back soon after previous treatment. You also can't have had any HER2-targeted treatments before. Some other health conditions, like serious heart problems or active bleeding in your stomach or bowel, would also prevent you from joining. The medical team will check your overall health carefully to make sure the study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you at least 18 years old?
  2. Have you been diagnosed with HER2-positive stomach or gastroesophageal junction cancer?
  3. Has your cancer started to spread or is it locally advanced?
  4. Have you NOT received any treatment for this cancer yet?
  5. Are you generally well and active enough for daily tasks?
  6. Do you not have any major heart problems?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two groups, like flipping a coin. You won't know which group you're in, and neither will your doctors usually (this is called 'double-blind'). You'll receive treatments every three weeks. This treatment will continue for as long as it helps you and you can manage any side effects, or until your doctor decides it's no longer the best option. You'll have regular appointments for check-ups, blood tests, and scans to see how you're responding and to monitor for side effects. The total length of your participation will depend on how you respond to the treatment.

Potential risks and benefits

Taking part in a clinical trial might offer benefits like access to a new treatment before it's widely available, and you'll be closely monitored by a medical team. However, there are also risks, as the new medicine HLX22 could have unknown side effects or might not work better than existing treatments. All medications have potential side effects, and chemotherapy can cause tiredness, sickness, and hair loss. You will be told about all known risks before you decide to join. Remember, taking part is completely voluntary, and you can withdraw from the study at any time without it affecting your usual medical care.

Locations (208)

  • Los Angeles Cancer Network
    Verified postcode
    Anaheim, United States· Recruiting
  • OPN - Oncology Physician Network (Los Alamitos)
    Verified postcode
    Los Alamitos, United States· Recruiting
  • Banner MD Anderson Cancer Center
    Verified postcode
    Greeley, United States· Recruiting
  • Advanced Research LLC
    Verified postcode
    Deerfield Beach, United States· Recruiting
  • Florida Cancer Specialist - South
    Verified postcode
    Fort Myers, United States· Recruiting
  • BRCR Medical Center
    Verified postcode
    Plantation, United States· Recruiting
  • Napa Research
    Verified postcode
    Pompano Beach, United States· Recruiting
  • Florida Cancer Specialist - North
    Verified postcode
    St. Petersburg, United States· Recruiting
  • Florida Cancer Specialist - East
    Verified postcode
    West Palm Beach, United States· Recruiting
  • Northwestern University
    Verified postcode
    Chicago, United States· Recruiting
  • University of Chicago
    Verified postcode
    Chicago, United States· Recruiting
  • Mission Cancer + Blood (Exigent Network)
    Verified postcode
    Des Moines, United States· Recruiting

Common questions

What is 'HER2-positive' cancer?

HER2-positive means the cancer cells have a lot of a specific protein called HER2 on their surface. This helps doctors choose treatments that target this protein.

What is the gastroesophageal junction?

This is the area in your body where your food pipe (oesophagus) connects to your stomach.

What does 'randomized' mean?

It means you'll be put into one of the study groups by chance, like drawing numbers from a hat. This helps make the study fair.

What is a 'placebo'?

A placebo is a dummy medicine that looks like the real drug but contains no active ingredients. It's used to compare the new drug's effects accurately.

Can I stop participating in the study at any time?

Yes, you can choose to leave the study at any point. It's your decision, and it won't affect your regular medical care.

How to find out more

Ying Li

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastu…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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