TISLELIZUMAB for Locally advanced rectal cancer | Rectal cancer stage II | Rectal cancer stage III

Inclusion criteria

• {"criterion_text":"- •\tSubjects with histologically confirmed primary (non-recurrent) LARC (tumor ≤<12 cm from the anal verge, as assessed by rigid proctoscopy), stage II (T3-4 N0 M0) or stage III (TX N1-2 M0) according to base-line pelvic MRI and PET-CT."}
• {"criterion_text":"- •\tPatients who are planned for TNT (total neoadjuvant treatment) and are surgical candidates as determined by the treating physician."}
• {"criterion_text":"- •\tNo prior chemotherapy, immunotherapy, radiotherapy or surgery for rectal cancer."}
• {"criterion_text":"- •\tNo prior radiotherapy to the pelvis, for any reason."}
• {"criterion_text":"- •\tAble to provide the FFPE block or 10 unstained slides from the colonoscopy for confirmation of the diagnosis, CPS (PD-L1 combined positive score) status and for investigational purposes."}
• {"criterion_text":"- •\tAge ≥ > 18 years."}
• {"criterion_text":"- •\tEastern Cooperative Oncology Group (ECOG) performance status (PS) < 2."}
• {"criterion_text":"- •\tScreening laboratory values must meet the following criteria (using CTCAE v5.0): i)\tWBC ≥ 2000/µL ii)\tNeutrophils ≥ 1500/ µL iii)\tPlatelets ≥ 100 x 10^3 µL iv)\tHemoglobin ≥ 9.0 g/dL v)\tSerum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min (using the Cockcroft Gault formula) vi)\tAST and ALT ≤ 2.5 x ULN vii)\tTotal bilirubin ≤ 1.5 x ULN (total bilirubin must be < 3 x ULN for patients with Gilberts syndrome)"}
• {"criterion_text":"- •\tAbility to swallow tablets."}
• {"criterion_text":"- •\tAdequate contraception in fertile patients; using a highly effective method of birth control for the duration of the study, and for at least 9 months after the last dose of chemotherapy and 120 days after the last dose of immunotherapy."}
• {"criterion_text":"- •\tWomen of childbearing potential must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to the start of treatment."}
• {"criterion_text":"- •\tWomen must not be breastfeeding."}
• {"criterion_text":"- •\tSigned written IRB approved informed consent. This must be obtained before the performance of any protocol related procedure that are not part of normal subject care. Subjects must be willing and able to comply with scheduled visits, treatments, and laboratory testing."}

Exclusion criteria

• {"criterion_text":"- •\tActive or background history of an autoimmune disease except for type I diabetes mellitus, hypothyroidism requiring hormone replacement only and skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment."}
• {"criterion_text":"- Patients with mismatch repair deficient (MMRd) / microsatellite instability- high (MSI-H) tumors."}
• {"criterion_text":"- Any evidence of interstitial lung disease or active, noninfectious pneumonitis"}
• {"criterion_text":"- •\tMedical history of vasculitis."}
• {"criterion_text":"- •\tPrior organ transplant, including allogenic bone marrow transplantation."}
• {"criterion_text":"- •\tGrade > 1 peripheral sensory neuropathy."}
• {"criterion_text":"- •\tPrior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways."}
• {"criterion_text":"- •\tAny prior active malignancy ≤ 2 years before trial entry except for any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)."}
• {"criterion_text":"- •\tAny serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the subject to receive protocol therapy."}
• {"criterion_text":"- •\tKnown history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)."}
• {"criterion_text":"- •\tKnown acute hepatitis B, known chronic hepatitis B infection with active untreated disease, or known active hepatitis C infection. In participants with a history of HBV or HCV, participants with detectable viral loads will be excluded."}
• {"criterion_text":"- Current or prior use of immunosuppressive medication within 14 days before the first dose of study treatment"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the 3-year TME-free survival rates (intention to treat, ITT)","definition_or_measurement_approach":"3-year TME-free survival rates measured in the intention-to-treat (ITT) population (compare 3-year TME-free survival of investigational vs standard regimens)."}

Secondary endpoints

• {"endpoint_text":"- ­\t3-year TME-free survival (CPS≥1%)","definition_or_measurement_approach":"3-year TME-free survival measured in the CPS ≥1% subgroup."}
• {"endpoint_text":"- ­\tcCR","definition_or_measurement_approach":"Complete clinical response (cCR) as defined by study assessments (definition not further specified in provided data)."}
• {"endpoint_text":"- ­\tDFS","definition_or_measurement_approach":"Disease-free survival (DFS) as an outcome measure (specific definition not provided in the available data)."}
• {"endpoint_text":"- ­\tPFS","definition_or_measurement_approach":"Progression-free survival (PFS) as an outcome measure (specific definition not provided in the available data)."}
• {"endpoint_text":"- ­\tOS rates","definition_or_measurement_approach":"Overall survival (OS) rates (specific timepoints and definitions not provided in the available data)."}
• {"endpoint_text":"- ­\tsafety and toxicity profile","definition_or_measurement_approach":"Safety and toxicity profile to be defined/assessed per study (CTCAE v5.0 referenced elsewhere for labs); full safety assessment details not provided in the available data."}
• {"endpoint_text":"- ­\tpatient-reported functional outcomes and QoL (quality of life) with EORTC QLQ-C30 and CR-29","definition_or_measurement_approach":"Patient-reported functional outcomes and quality of life measured using EORTC QLQ-C30 and CR-29 instruments."}

Germany

Earliest CTIS Part Ii Submission Date

16-01-2026

Latest Decision Or Authorization Date

10-02-2026

Processing Time Days

25

Number Of Sites

4

Number Of Participants

67

Primary sponsor

Full Name

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany

Third parties

• {"country":"","full_name":"BeOne Switzerland GmbH.","duties_or_roles":"Monetary support","organisation_type":""}