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New treatment option for Locally Advanced Rectal Cancer
Official title CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer
ClinicalTrials.gov ID: NCT06281405
What this study is testing
What is PD-1 inhibitor?
PD-1 inhibitor is an investigational medicine, being studied as a potential treatment for locally advanced rectal cancer.
Also referred to as Toripalimab.
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
- TORCH-iTNT is a prospective, multicentre, randomized phase II trial. 198 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with total neoadjuvant therapy (TNT) and assigned to Group A and Group B (1:1).
- 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 to 70
You may be able to join if
- Age 18-70 years old, female and male;
- Pathological confirmed adenocarcinoma;
- The distance from anal verge ≤ 10 cm;
- MSI/MMR status: MSS/pMMR;
- Clinical stage T3-4 and/or N+, without distance metastases;
You likely can't join if
- Pregnancy or breast-feeding women;
- Known history of other malignancies within 5 years;
- Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);
- Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;
- Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;
- Uncontrolled infection which needs systemic therapy;
See the full eligibility criteria
- Age 18-70 years old, female and male;
- Pathological confirmed adenocarcinoma;
- The distance from anal verge ≤ 10 cm;
- MSI/MMR status: MSS/pMMR;
- Clinical stage T3-4 and/or N+, without distance metastases;
- At least one of the following factors is present: distance from the anus ≤5 cm, cT4, cN2, positive cMRF, positive cEMVI, or positive lateral lymph nodes;
- KPS ≥ 70;
- No radiotherapy, chemotherapy, immunotherapy, or any other anti-tumor therapy had been administered prior to enrollment;
- Baseline blood and biochemical indicators meet the following criteria: neutrophils ≥ 1.5 × 10\^9/L, Hb ≥ 90 g/L, PLT ≥ 100 × 10\^9/L, ALT/ AST ≤ 2.5 ULN, Cr ≤ 1 ULN;
- With good compliance and signed the consent form.
- Pregnancy or breast-feeding women;
- Known history of other malignancies within 5 years;
- Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);
- Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;
- Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;
- Uncontrolled infection which needs systemic therapy;
- Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection;
- Allergic to any component of the therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. 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.