Combining Tislelizumab with Chemoradiation for Advanced Rectal Cancer

Total Neoadjuvant Therapy Combined With Tislelizumab for Local Advanced Phase II Randomized Controlled Clinical Study of Middle and Low Rectal Cancer

This study is testing if adding a new drug called Tislelizumab to standard treatment can help people with advanced rectal cancer feel better and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Friendship Hospital (Academic / other)
• Drugs / interventions: immunotherapy, tislelizumab, chemotherapy, radiation
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05845268 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of long-term concurrent chemoradiotherapy combined with Tislelizumab, a PD-1 inhibitor, for patients with locally advanced low rectal cancer. It is a randomized, open-label, multi-center phase II trial involving 102 participants aged 18-75 years. Patients will be assigned to either an experimental group receiving Tislelizumab or a control group receiving standard chemoradiation. The study aims to assess clinical and pathological response rates, survival outcomes, and quality of life metrics.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with stage II-III rectal adenocarcinoma who can undergo major abdominal surgery.

Not a fit: Patients with a history of immune diseases or prior treatments involving immunotherapy or radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and survival rates for patients with locally advanced rectal cancer.

How similar studies have performed: Other studies have shown promising results with PD-1 inhibitors in cancer treatment, suggesting potential for success in this novel application.

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

Where this trial is running

Beijing, Beijing

• Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Zhang Zhongtao — Beijing Friendship Hospital
• Study coordinator: Zhang Zhongtao, MD

Conditions Locally Advanced Rectal Cancer; neoadjuvant; Tislelizumab; PD-1; chemoradiation; LARC; randomized; controlled