Rectal cancer stage II – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Fri, 12 Jun 2026 11:23:21 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Rectal cancer stage II – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 Study comparing treatment with or without tislelizumab for patients with locally advanced rectal cancer to see if surgery can be avoided https://clinicaltrials.eu/trial/study-comparing-treatment-with-or-without-tislelizumab-for-patients-with-locally-advanced-rectal-cancer-to-see-if-surgery-can-be-avoided/ Thu, 30 Apr 2026 13:08:48 +0000 https://clinicaltrials.eu/trial/study-comparing-treatment-with-or-without-tislelizumab-for-patients-with-locally-advanced-rectal-cancer-to-see-if-surgery-can-be-avoided/ 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.

]]> Study of Regorafenib and Nivolumab with radiotherapy for patients with stage II-III rectal cancer before surgery https://clinicaltrials.eu/trial/study-of-regorafenib-and-nivolumab-with-radiotherapy-for-patients-with-stage-ii-iii-rectal-cancer/ Wed, 29 Apr 2026 15:00:02 +0000 https://clinicaltrials.eu/trial/study-of-regorafenib-and-nivolumab-with-radiotherapy-for-patients-with-stage-ii-iii-rectal-cancer/ This study focuses on patients with stage II-III rectal cancer that is locally advanced. The treatment combines three different approaches: two medications – nivolumab and regorafenib – along with short-course radiotherapy. Both medications are given to patients before and after the radiotherapy treatment.

Nivolumab is administered through an intravenous infusion (through a vein), while regorafenib is taken as tablets by mouth. The study aims to determine if this combination of treatments can achieve a complete response in patients whose tumors have specific characteristics (referred to as pMMR/MSS tumors). A complete response means that there are no signs of cancer remaining after the treatment.

During the study, patients receive nivolumab infusions at a maximum daily dose of 240 mg, with a total maximum dose of 1200 mg over 5 weeks. Regorafenib tablets are given at a maximum daily dose of 60 mg, with a total maximum dose of 2040 mg over 34 weeks. Patients undergo regular medical examinations and imaging tests throughout the treatment period to monitor their response to the therapy.

]]> Study on Adjuvant Therapy with Capecitabine for Stage II Colon and Rectal Cancer Patients with Positive ctDNA After Tumor Removal https://clinicaltrials.eu/trial/study-on-adjuvant-therapy-with-capecitabine-for-stage-ii-colon-and-rectal-cancer-patients-with-positive-ctdna-after-tumor-removal/ Wed, 29 Apr 2026 14:30:07 +0000 https://clinicaltrials.eu/trial/study-on-adjuvant-therapy-with-capecitabine-for-stage-ii-colon-and-rectal-cancer-patients-with-positive-ctdna-after-tumor-removal/ This clinical trial is focused on studying *colon cancer stage II* and *rectal cancer stage II*. The treatment being investigated is a medication called *capecitabine*, which is a type of chemotherapy taken orally. The purpose of the study is to evaluate the effectiveness of additional therapy, known as adjuvant therapy, in patients who have had surgery to remove their primary tumor. The study aims to compare the time patients remain free from cancer, known as disease-free survival, in those who have a specific marker in their blood called *circulating tumor DNA* (ctDNA) after surgery, with and without the additional therapy.

Participants in the study will be randomly assigned to receive either the chemotherapy treatment with *capecitabine* or a follow-up without additional therapy. The study will monitor the participants over time to see if the cancer returns, spreads, or if a new cancer develops. The study will also look at overall survival, which means the length of time patients live after the treatment, regardless of whether the cancer comes back. The study will continue to collect data on the participants’ health and any side effects they may experience from the treatment.

The trial will also explore other factors, such as the level of ctDNA before any recurrence of cancer and how it changes during or after chemotherapy. This information will help researchers understand the relationship between ctDNA levels and the risk of cancer returning or spreading. The study is expected to provide valuable insights into the best treatment approaches for patients with stage II colon and rectal cancer.

]]> Study Comparing Short-Course Radiotherapy and Drug Combination for Older Patients with Locally Advanced Rectal Cancer https://clinicaltrials.eu/trial/study-comparing-short-course-radiotherapy-and-drug-combination-for-older-patients-with-locally-advanced-rectal-cancer/ Wed, 29 Apr 2026 14:25:30 +0000 https://clinicaltrials.eu/trial/study-comparing-short-course-radiotherapy-and-drug-combination-for-older-patients-with-locally-advanced-rectal-cancer/ This clinical trial is focused on studying treatments for locally advanced rectal cancer in older patients. The trial compares two treatment approaches: short-course radiotherapy (SCRT) followed by surgery, with or without additional chemotherapy, and total neoadjuvant therapy (TNT), which involves a combination of treatments given before surgery. The main goal is to determine which approach offers a better balance between effectiveness and safety for older patients.

Participants in the study will receive various medications as part of their treatment. These include Capecitabine, Oxaliplatin, and Fluorouracil, which are commonly used in cancer treatment. Additionally, supportive medications such as Ondansetron, Dexamethasone, Folinic Acid, and Metoclopramide may be administered to help manage side effects and improve the overall treatment experience. Some patients may receive a placebo as part of the study design.

The study will follow participants over a period of time to assess outcomes such as overall survival, progression-free survival, and the occurrence of side effects. The trial aims to provide valuable information on the best treatment strategy for older patients with this type of cancer, ultimately helping to improve their quality of life and treatment outcomes.

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