Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

A randomized, open label, multicenter phase II/III trial of sacituzumab govitecan compared to standard of care in metastatic, refractory colorectal cancer patients (TROPHIT1)

This research study, called TROPHIT1, is investigating a new medication, sacituzumab govitecan, for people in the UK with advanced bowel cancer (colorectal cancer) that has spread to other parts of the body and hasn't improved with other treatments. The study aims to see if this new drug is better than existing standard treatments like regorafenib, trifluridine, or bevacizumab, or combinations of these. Doctors will compare how long people on the new treatment live without their cancer getting worse, compared to those on standard care. This is a crucial step in finding more effective ways to treat this type of cancer.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Universitaetsklinikum Heidelberg AöR

Enrolment target

Start

22 Apr 2024

Metastatic Colorectal cancer (mCRC)

What is this study about?

This study is for people in the UK who have metastatic colorectal cancer, which means bowel cancer that has spread to other parts of the body. Unfortunately, for these patients, standard treatments may not always work as well as hoped, or the cancer might start growing again. This study is testing a new medicine called sacituzumab govitecan.

The main aim of the study, called TROPHIT1, is to find out if sacituzumab govitecan can stop the cancer from growing for longer compared to the usual treatments currently available, such as regorafenib, trifluridine, or combinations including bevacizumab. Doctors will also check how long people live overall, how much the cancer shrinks or stays stable, and how long any improvements last.

By comparing this new drug with current treatments, researchers hope to discover if it offers a better option for people when other treatments haven’t been successful. Finding new and more effective treatments is incredibly important for improving the lives of people with advanced bowel cancer.

Key takeaways

Tests a new treatment for advanced bowel cancer.
Compares the new drug to standard care options.
Aims to find out if the new drug stops cancer growth for longer.
Involves regular hospital visits and health monitoring.
You might receive the new drug or a standard treatment.
Participation is voluntary and you can withdraw anytime.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women can take part.

Generally, participants will have bowel cancer that has spread to other parts of the body (metastatic colorectal cancer). You will also have received previous treatments for your cancer that have either stopped working or your cancer has continued to grow despite them.

There will be other specific medical checks and tests that the study doctors will need to carry out to ensure it's safe and appropriate for you to join. It's important to discuss all your medical history with your doctor to see if you meet all the criteria.

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.

Are you 18 years old or older?
Do you have bowel cancer that has spread?
Has your cancer not responded well to previous treatments?
Are you able to travel to the study site for appointments?
Are you willing to potentially receive either the new drug or a standard treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to either receive the new drug (sacituzumab govitecan) or one of the standard treatments. This assignment is chosen randomly, like flipping a coin. You will have regular visits to the hospital for check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. The specific schedule of visits and tests will depend on which treatment you receive.

Throughout the study, doctors and nurses will closely monitor you for any side effects and to see how your cancer is responding. The total time you spend in the study will vary, depending on how you respond to the treatment and until your doctor decides it's no longer the best option for you. Even after stopping the study treatment, there might be follow-up appointments to track your long-term health.

Potential risks and benefits

Taking part in this study could potentially offer you access to a new treatment that might be more effective than current options for advanced bowel cancer. However, as with all medications, there's a risk of side effects, which could range from mild to serious. The study team will explain these in detail. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Germany

Common questions

What is 'metastatic colorectal cancer'?

This means bowel cancer that has spread from where it started to other parts of your body.

What does 'standard of care' mean in this study?

It refers to the common and approved treatments doctors would usually give for advanced bowel cancer, such as regorafenib or trifluridine.

Will I definitely get the new drug?

No, you will be randomly assigned to either receive the new drug or one of the standard treatments; it's like a lottery.

What is 'Progression Free Survival'?

This is how long you live without your cancer growing or getting worse.

Can I stop being in the study whenever I want?

Yes, you can choose to leave the study at any time, and it won't affect your future medical care.