RecruitingPHASE2INTERVENTIONAL

Total Neoadjuvant Treatment With or Without Tislelizumab for Locally Advanced Rectal Cancer.

This research study is for people with locally advanced rectal cancer, which is a type of bowel cancer that has grown into nearby tissues but hasn't spread far. Doctors are trying to find out if adding a new drug called Tislelizumab to the usual treatment can improve outcomes. The standard treatment involves chemotherapy and radiation before surgery. This study will see if Tislelizumab, given during the chemotherapy phase, can help more patients respond so well that they can avoid surgery altogether, or at least delay it significantly. The main goal is to improve the chances of avoiding surgery for at least three years, as surgery can have a big impact on quality of life.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

brenner baruch

Enrolment target

134

Start

23 Jul 2025

Estimated completion

01 Aug 2030

Locally Advanced Rectal Cancer (LARC)

What is this study about?

This clinical trial is designed for people who have locally advanced rectal cancer. This means the cancer is in the rectum, which is the last part of the large bowel, and has started to grow into nearby tissues but hasn't spread to distant parts of the body. The standard way to treat this type of cancer often involves a combination of chemotherapy and radiotherapy, usually given before surgery. This combined approach is called 'total neoadjuvant treatment' (TNT), and it aims to shrink the cancer as much as possible before any operation.

The main idea behind this study is to see if adding a new type of drug, called Tislelizumab, can make the TNT even better. Tislelizumab is an immunotherapy drug, which means it works by helping your body's immune system fight the cancer. Doctors hope that by including Tislelizumab, more patients might have a very good response to treatment. For some people, this could mean the cancer shrinks so much that they might not need surgery, or at least can delay it for a long time. Avoiding or delaying surgery, which can be a major operation, is a really important goal for patients.

Researchers will compare two groups of patients. One group will receive the standard TNT treatment. The other group will receive the standard TNT treatment plus Tislelizumab. By comparing the results, doctors want to find out if adding Tislelizumab leads to a higher chance of avoiding surgery for at least three years for people with locally advanced rectal cancer. This could potentially offer a new and improved treatment option in the future.

Key takeaways

This study evaluates adding an immunotherapy drug (Tislelizumab) to standard rectal cancer treatment.
It targets locally advanced rectal cancer (not spread far).
The main goal is to see if more patients can avoid surgery in the long term (3 years).
Participation involves random assignment to two treatment groups.
Treatments include radiotherapy, chemotherapy, and potentially Tislelizumab.
Regular follow-up and monitoring will be part of the study.

Who may be eligible?

To join this study, you need to have locally advanced rectal cancer that has been confirmed by a biopsy. The cancer should be at a specific stage (T3-4 N0 or TX N+), meaning it has grown into the bowel wall but hasn't spread widely, and it needs to be located within 12 cm of the anas, as measured by a doctor.

You must be at least 18 years old and generally well enough to undergo the treatments, as decided by your doctors. You cannot have had any previous chemotherapy, immunotherapy, or radiotherapy for rectal cancer, or any radiotherapy to your pelvic area for other reasons in the past. Your blood test results also need to be within a healthy range, and if you are a woman who can have children, you must use effective contraception and not be breastfeeding.

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.

Do I have locally advanced rectal cancer confirmed by a doctor?
Am I at least 18 years old?
Have I had no previous chemotherapy, immunotherapy, or radiotherapy for rectal cancer?
Are my general health and blood test results within healthy ranges?
If I am a woman who can have children, am I willing to use effective contraception and not breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you will first go through a screening process to make sure the study is right for you. This will involve detailed checks of your medical history, physical exams, and blood tests. If you meet all the requirements, you will then be randomly assigned to one of two groups – like drawing lots – so that each group has an equal chance.

One group will receive the standard course of radiotherapy (for 6 weeks) followed by 16 weeks of chemotherapy. The other group will receive the same course of radiotherapy, but then have Tislelizumab added to their 16 weeks of chemotherapy. The chemotherapy and Tislelizumab (if in that group) will be given every two weeks. After all treatments are finished, you will have more scans and tests to see how the cancer has responded. If the cancer has gone or is very small, your doctors might suggest closely monitoring you instead of immediate surgery. If there’s still a noticeable tumour, you would then have surgery. All participants will be followed up according to standard medical guidelines to track their health and cancer over time.

Potential risks and benefits

Participating in this study might offer you the potential benefit of a new treatment that could reduce the need for major surgery or significantly delay it, which could improve your quality of life. However, like all medical treatments, there are potential risks, including side effects from the chemotherapy, radiotherapy, or Tislelizumab. These side effects can vary from person to person. All study treatments will be carefully monitored by your medical team. 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 medical care.

Locations (2)

Johannes Gutenberg-University Clinic, Mainz, Germany 1.Dept. Medicine, Prof. Peter R. Galle
Verified postcode
Mainz, Germany· Not yet recruiting
Davidoff Cancer Center, Rabin Medical Center, Beilinson Hospital
Verified postcode
Petah Tikva, Israel· Recruiting

Common questions

What is 'locally advanced rectal cancer'?

It means the cancer is in the rectum and has started to grow into nearby tissues but hasn't spread to distant parts of the body.

What is Tislelizumab?

Tislelizumab is a type of immunotherapy drug that helps your body's own immune system find and fight cancer cells.

What is 'total neoadjuvant treatment' (TNT)?

It's a common approach where patients receive chemotherapy and radiotherapy before any surgery to shrink the cancer.

Why might I want to avoid surgery?

Surgery for rectal cancer can be a major operation and can sometimes affect your digestion and quality of life. Avoiding or delaying it is often beneficial.

Will I definitely get the new drug?

No, you will be randomly assigned to either receive the standard treatment or the standard treatment plus Tislelizumab. It's like flipping a coin.

How to find out more

Baruch Brenner, M.D

brennerb@clalit.org.il +972-50-4065452 Official trial record

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