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Study comparing treatment with or without tislelizumab for patients with locally advanced rectal cancer to see if surgery can be avoided

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at Locally Advanced Rectal Cancer, which is cancer in the lower part of the large intestine that has grown into deeper layers of the bowel wall or has spread to nearby lymph nodes but has not spread to distant parts of the body. The treatment being tested is called Tislelizumab, which is also known by its code name BGB-A317. This medication is given through an intravenous infusion, which means it is delivered directly into a vein over a period of time. The study will compare two groups of patients: one group will receive standard total neoadjuvant treatment, which is a combination of chemotherapy and radiation therapy given before surgery, while the other group will receive the same treatment plus Tislelizumab.

The purpose of this study is to compare how long patients in both groups can avoid having a major surgery called TME (total mesorectal excision) over a three-year period. TME is a surgical procedure to remove the rectum and surrounding tissue. Patients in the study will receive their assigned treatment before any surgery is planned. The maximum daily dose of Tislelizumab will be 150 milligrams, with a maximum total dose of 1200 milligrams over a treatment period of up to 16 weeks. The study will also look at other outcomes such as how well the tumor responds to treatment, survival rates, side effects, and how the treatment affects patients' quality of life.

During the study, patients will be randomly assigned to one of the two treatment groups. Both groups will receive chemotherapy and radiation therapy as part of their neoadjuvant treatment, which is treatment given before the main treatment to help shrink the tumor. One group will also receive Tislelizumab along with the standard treatment. Patients will be monitored throughout the treatment period and for several years afterward to measure the effectiveness of the treatment and any side effects that may occur. The study will collect tissue samples from the initial colonoscopy to confirm the diagnosis and for research purposes.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase with chemotherapy and radiotherapy

    Your treatment will begin with a combination of chemotherapy and radiotherapy. Chemotherapy refers to medications that help fight cancer cells, while radiotherapy uses targeted radiation to treat the tumor in your rectum.

    If you are assigned to the group receiving tislelizumab, this medication will be added to your treatment. Tislelizumab is an immunotherapy drug, which means it helps your immune system recognize and fight cancer cells.

    Tislelizumab is given through an intravenous infusion, which means it is delivered directly into your vein through a drip. The medication comes as a concentrated solution that is mixed before being given to you.

    This initial treatment phase is called total neoadjuvant treatment, which means you receive all non-surgical cancer treatments before any potential surgery.

  2. Step 2

    Monitoring and assessment period

    Throughout your treatment, regular assessments will be conducted to monitor how your body is responding to the medications and to check for any side effects.

    Blood tests will be performed to ensure your blood cell counts, liver function, and kidney function remain within safe levels.

    Imaging tests may be performed to evaluate how the tumor is responding to the treatment.

  3. Step 3

    Treatment completion and response evaluation

    After completing the initial treatment phase, your medical team will assess how well the tumor has responded to the therapy.

    The goal is to achieve a complete clinical response, which means the tumor shows no signs of active cancer based on examinations and imaging tests.

    Your doctor will determine whether surgery is necessary or if you can continue with observation without immediate surgical removal of the rectum.

  4. Step 4

    Long-term follow-up period

    You will be monitored for 3 years to assess whether you remain free from the need for TME surgery. TME stands for total mesorectal excision, which is a type of surgery to remove the rectum.

    Regular check-ups will be scheduled to monitor your health and detect any signs of cancer recurrence.

    You will be asked to complete questionnaires about your quality of life and how your body is functioning after treatment.

    The study will continue to collect information about your health status, including disease-free survival (time without cancer returning), progression-free survival (time without cancer getting worse), and overall survival (how long you live after treatment).

    The entire study is expected to continue until December 2032 to gather complete information about long-term outcomes.

Who can join the trial?

13 criteria

  • You must have a diagnosis of rectal cancer (cancer in the lower part of the large intestine) confirmed by laboratory examination of tissue samples. The tumor must be located within 12 centimeters from the anal opening (the opening where stool leaves the body), and the cancer must be at a specific stage called stage II or stage III, as confirmed by imaging scans.
  • If you are able to have children, you must use a very effective method of birth control during the study and for at least 9 months after the last dose of chemotherapy and 120 days after the last dose of immunotherapy (a type of cancer treatment that helps your immune system fight cancer).
  • If you are a woman who could become pregnant, you must have a negative pregnancy test within 7 days before starting treatment.
  • If you are a woman, you must not be breastfeeding.
  • You must sign a consent form after understanding the study details. You must be willing and able to attend all scheduled visits and follow the treatment plan.
  • You must be planned to receive total neoadjuvant treatment (treatment given before surgery) and be suitable for surgery, as decided by your doctor.
  • You must not have received any previous chemotherapy (medication to treat cancer), immunotherapy, radiotherapy (treatment using radiation), or surgery for rectal cancer.
  • You must not have received any previous radiotherapy to the pelvis (lower part of the abdomen) for any reason.
  • You must be able to provide tissue samples from your colonoscopy (a procedure to examine the inside of the colon) for testing purposes.
  • You must be 18 years of age or older.
  • Your general health and ability to perform daily activities must be good, with an ECOG performance status (a scale measuring how well you can function) of less than 2.
  • Your blood test results must meet specific requirements, including adequate levels of white blood cells (cells that fight infection), neutrophils (a type of white blood cell), platelets (cells that help blood clot), hemoglobin (protein in red blood cells that carries oxygen), and proper kidney and liver function.
  • You must be able to swallow tablets.

Who cannot join the trial?

3 criteria

  • The source data does not contain specific exclusion criteria (reasons why patients cannot participate in this study)
  • Without detailed exclusion criteria information, it is not possible to list the specific conditions or situations that would prevent participation in this clinical trial
  • Exclusion criteria typically include factors such as other serious health conditions, certain medications being taken, previous treatments, or test results that fall outside acceptable ranges, but these specific details are not provided in the available data
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Investigated drugs

Tislelizumab is a type of immunotherapy medication that helps your immune system recognize and fight cancer cells. In this trial, it is being tested to see if adding it to standard treatment can improve outcomes for patients with locally advanced rectal cancer.

What is already known about the treatment

Tislelizumab – Tislelizumab is an immunotherapy medication given through an intravenous infusion (injection into a vein) and is currently being studied in clinical trials for treating locally advanced rectal cancer. This drug works by blocking a protein called PD-1 on immune cells, which helps the body's immune system recognize and attack cancer cells more effectively. It belongs to a class of medications known as immune checkpoint inhibitors, which are designed to enhance the natural ability of the immune system to fight cancer.

Investigated diseases

Locally Advanced Rectal Cancer – Locally advanced rectal cancer is a type of cancer that develops in the rectum, which is the final section of the large intestine before the anus. In this stage, the tumor has grown through several layers of the rectal wall and may have spread to nearby lymph nodes, but has not yet spread to distant organs. Stage II locally advanced rectal cancer means the tumor has grown deep into the rectal wall or through it to nearby tissues, but has not reached the lymph nodes. Stage III locally advanced rectal cancer indicates that the cancer has spread to nearby lymph nodes regardless of how deep the tumor has penetrated the rectal wall. The disease progresses as cancer cells multiply and invade deeper layers of tissue and potentially spread to regional lymph nodes. Without intervention, the cancer may continue to grow locally and eventually spread to distant parts of the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522120-28-00Protocol codeTOTALEstimated enrolment134 patientsSponsorRabin Medical Center

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).