Total Neoadjuvant Therapy Combined With Tislelizumab for Local Advanced of Middle and Low Rectal Cancer

Launched by BEIJING FRIENDSHIP HOSPITAL · Apr 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally advanced rectal cancer, specifically looking at how well a combination of a medication called tislelizumab and long-term chemotherapy and radiation therapy works compared to just chemotherapy and radiation therapy alone. The goal is to see if this combination can lead to better outcomes, such as a complete disappearance of the cancer before surgery. Researchers will track various results, including how many patients respond to the treatment, how long they remain cancer-free, and their overall quality of life.

To be eligible for this trial, participants must be adults aged 18 or older with stage II or III rectal cancer located close to the anus. They need to be in good health overall and able to undergo major surgery. Importantly, they must agree to follow the study guidelines and provide consent for their medical information to be used in the research. Those who have had other cancers, recent major surgeries, or certain health conditions may not qualify. Participants can expect close monitoring throughout the trial and will be randomly assigned to one of the two treatment groups. This trial is currently recruiting participants, and it aims to better understand how to improve treatment for rectal cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients have been fully aware of the content of this study and signed the informed consent voluntarily;
• • Patients with rectal cancers must satisfied all the following conditions:Stage II/III LARC (cT3-4aN0M0 and cT1-4aN1-2M0);Tumor distal location ≤ 10 cm from anal verge (MRI diagnosed);
• • Patients regardless of gender with aged ≥18 years and ECOG score of 0 or 1;
• • Physical and viscera function of patients can withstand major abdominal surgery;
• • Patients are willing and able to follow the study protocol during the study;
• • Patients give consent to the use of blood and pathological specimens for study;
• • Within 28 days prior to enrolment, we must confirm a negative serological pregnancy test for child-bearing age women and they agree to use effective contraception for the duration of drug use and for 60 days after the last dose.
• Exclusion Criteria:
• • Patients have a present or previous active malignancy except the diagnosis of rectal cancer this time;
• • Patients underwent major surgery within 4 weeks prior to study treatment;
• • Patients have any condition affects the absorption of capecitabine through gastrointestinal tract;
• • Patients have severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;
• • Patients who are allergic to any of the ingredients under study;
• • Patients with severe concomitant diseases with estimated survival ≤ 5 years;
• • Patients with present or previous moderate or severe liver and kidney damage presently or previously;
• • Patients have received other study medications or any immunotherapy currently or in the past;
• • Patients preparing for or previously received organ or bone marrow transplant;
• • Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of study therapy;
• • Patients with congenital or acquired immune deficiency (such as HIV infection);
• • If patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder, the investigator will determine whether the clinical severity prevents the signing of informed consent or affects the patient's oral medication compliance;
• • Patients with other factors that may affect the study results or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment and severe laboratory examination abnormalities.
• • Pregnant or lactating women