A phase II, open-label, randomized, multi-center study comparing the efficacy and safety of Sacituzumab govitecan versus investigator's choice in patients with cancer of unknown primary (CUP) who are relapsed after or refractory to platinum-based chemotherapy (SACICUP)
Cancer of unknown primary (CUP) is a condition where cancer cells have spread in the body, but doctors cannot find where the cancer originally started. The usual first treatment is chemotherapy containing platinum medicines. However, if the cancer comes back or stops responding, standard options are limited. This trial compares a newer medicine called sacituzumab govitecan (also known as Trodelvy) with standard chemotherapy chosen by your doctor. Sacituzumab govitecan is designed to deliver medicine straight to cancer cells. Researchers want to see whether this newer drug gives people more time before their cancer worsens compared to standard chemotherapy. They will also look at overall survival, tumour shrinkage, side effects, and how the treatments affect day-to-day quality of life. Half of the participants will receive the new medicine, while the other half will receive standard chemotherapy.
At a glance
What is this study about?
Cancer of unknown primary, or CUP, means that doctors have found secondary cancer tumours in the body, but tests cannot show where the cancer first began. Because doctors do not know the exact starting point, choosing the most effective treatment can be challenging. Most people receive standard chemotherapy medicines containing platinum. If this first treatment stops working or the cancer grows back, doctors need better, more effective choices.
This study, called SACICUP, is testing a medicine called sacituzumab govitecan. This medicine works differently from traditional chemotherapy. It is a targeted drug that attaches directly to specific proteins found on many cancer cells and delivers a strong cancer-killing medicine right inside them. Researchers hope this direct attack will work better and cause fewer unwanted effects than standard chemotherapy drugs.
In this trial, patients will be randomly split into two groups. One group will receive sacituzumab govitecan, while the other will receive a standard chemotherapy chosen by their doctor. The main goal is to find out which treatment keeps the cancer from growing for longer. Researchers will also monitor safety, how well tumours shrink, and how patients feel during treatment.
Key takeaways
- The SACICUP trial tests whether sacituzumab govitecan works better than standard chemotherapy for cancer of unknown primary.
- It is for adults whose cancer has returned or progressed after platinum chemotherapy.
- Participants are randomly assigned to receive either the study medicine or standard chemotherapy via an intravenous drip.
- The main aim is to see which treatment keeps cancer stable for longer while checking side effects and quality of life.
- Participation is entirely voluntary and you can withdraw at any time.
Who may be eligible?
This trial is open to adults aged 18 and older who have been diagnosed with cancer of unknown primary (CUP). To take part, you must have already had platinum-based chemotherapy that has either stopped working or your cancer has returned after treatment.
You will need to be well enough to carry out basic daily tasks and attend regular hospital visits. Your doctor will also run blood tests and health checks to ensure your major organs, such as your liver, kidneys, and heart, are working safely enough for treatment.
You may not be eligible if you have certain other active medical conditions, severe infections, or if you have previously had this specific drug. Your hospital cancer team will look closely at your medical history to see if this trial is suitable 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.
- I am aged 18 or older.
- I have been diagnosed with cancer of unknown primary (CUP).
- I have already received platinum-based chemotherapy.
- My cancer has returned or worsened during or after that chemotherapy.
- I am well enough to attend regular hospital appointments and scans.
What does participation involve?
If you join the trial, a computer will assign you by chance to one of two treatment groups. You will receive either the study medicine (sacituzumab govitecan) or a standard chemotherapy selected by your doctor. Both treatments are given through a drip directly into a vein (an intravenous infusion) at the hospital.
You will attend regular clinic visits for treatment, blood tests, and health checks. Every few weeks, you will have body scans (such as CT scans) to see how your tumour is responding. You will also be asked to complete short surveys about your symptoms, daily activities, and quality of life.
You will continue to receive treatment for as long as your cancer remains stable and the side effects are manageable. Even after treatment finishes, the research team will keep in touch to check on your health.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What does 'cancer of unknown primary' mean?
It means doctors have found cancer that has spread in your body, but tests cannot reveal where in the body it first started.
Can I choose which treatment I get?
No. A computer assigns you to a group by chance. This is called randomisation, and it ensures the study results are fair and reliable.
Is sacituzumab govitecan a standard chemotherapy?
It is an antibody-drug conjugate. This is a targeted treatment that seeks out cancer cells and delivers a cancer-fighting medicine directly to them.
What happens if my cancer gets worse during the study?
Your team will do regular scans. If the scan shows the cancer is growing or if side effects become too difficult, you will stop the trial drug and discuss other care options with your doctor.
Can I leave the trial if I change my mind?
Yes. You can leave the study at any point without giving a reason. Your doctors will continue to give you the best available standard care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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