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New treatment option for Locally Advanced Rectal Cancer (LARC)
Official title Total Neoadjuvant Treatment With or Without Tislelizumab for Locally Advanced Rectal Cancer.
ClinicalTrials.gov ID: NCT06940388
What this study is testing
What is Tislelizumab?
Tislelizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced rectal cancer (larc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This prospective, multi-center, phase II randomized controlled trial will evaluate the actual benefit of adding immunotherapy with tislelizumab to the currently most effective approach against LARC, namely TNT. In this trial, we will harness several elements that may each potentially contribute to an overall high efficacy, at least in local outcomes: nCRT rather than SCRT, full length (8 cycles of mFOLFOX6) of consolidation chemotherapy, CIMT following nCRT (exploiting the upregulation of the immune response induced by the latter) and tislelizumab (with its theoretical advantage over other CPIs).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people with histologically confirmed primary (non-recurrent) LARC (tumor 12 cm or less from the anal verge, as assessed by rigid proctoscopy), stage...
- Patients who are planned for TNT and are surgical candidates as determined by the treating physician.
- No prior chemotherapy, immunotherapy, radiotherapy or surgery for rectal cancer.
- No prior radiotherapy to the pelvis, for any reason.
- Able to provide the FFPE block or 10 unstained slides from the colonoscopy for confirmation of the diagnosis, CPS status and for investigational...
You likely can't join if
- Active or background history of an autoimmune disease except for type I diabetes mellitus, hypothyroidism requiring hormone replacement only and skin...
- Medical history of vasculitis.
- Prior organ transplant, including allogenic bone marrow transplantation.
- Grade \> 1 peripheral sensory neuropathy.
- Prior 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...
- Any prior active malignancy \< 2 years before trial entry except for any locally recurring cancer that has been treated curatively (eg, resected...
See the full eligibility criteria
- people with histologically confirmed primary (non-recurrent) LARC (tumor 12 cm or less from the anal verge, as assessed by rigid proctoscopy), stage T3-4 N0 or TX N+ according to base-line pelvic MRI and PET-CT.
- Patients who are planned for TNT and are surgical candidates as determined by the treating physician.
- No prior chemotherapy, immunotherapy, radiotherapy or surgery for rectal cancer.
- No prior radiotherapy to the pelvis, for any reason.
- Able to provide the FFPE block or 10 unstained slides from the colonoscopy for confirmation of the diagnosis, CPS status and for investigational purposes.
- Age 18 years or more.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) \< 2.
- Screening laboratory values must meet the following criteria (using CTCAEv5.0): i) WBC \> 2000/µL ii) Neutrophils \> 1500/ µL iii) Platelets \> 100 x 103/ µL iv) Hemoglobin \> 9.0 g/dL v) Serum creatinine \ 60 mL/min...
- Ability to swallow tablets.
- Adequate 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...
- Women 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.
- Women must not be breastfeeding.
- Signed 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. people must be willing and able to comply with...
- Active 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...
- Medical history of vasculitis.
- Prior organ transplant, including allogenic bone marrow transplantation.
- Grade \> 1 peripheral sensory neuropathy.
- Prior 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.
- Any 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...
- Any 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...
- Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Known 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...
The study team makes the final eligibility decision.
Where it's taking place
- Mainz, Germany
- Petah Tikva, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mainz, Germany; Petah Tikva, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.