Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined With Toripalimab, Liposomal Irinotecan, and Capecitabine in the Treatment of pMMR Locally Advanced Rectal Adenocarcinoma With Low Rectal Involvement
- Registration Number
- NCT07104604
- Lead Sponsor
- Affiliated Cancer Hospital of Shantou University Medical College
- Brief Summary
The goal of this clinical trial is to evaluating the efficacy and safety of radiotherapy combined with Tislelizumab, Liposomal Irinotecan, and Capecitabine in patients with locally advanced mid-lower rectal cancer with pMMR.. Patients would be included as:1. Aged between 18-75 years, with no gender restrictions; 2. Biopsy pathology confirmed as pMMR type locally advanced mid-lower rectal adenocarcinoma (tumor lower margin ≤ 10 cm from the anal verge); 3.With the following high-risk factors: T3N+/T4/N2/EMVI+/MRF+/lateral lymph node metastasis/inability to preserve anal function during surgery; 4. No distant metastasis observed in routine chest and abdominal CT scans.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 59
- Age: 18-75 years, no gender restriction
- ECOG score 0-1
- Biopsy-confirmed pMMR (proficient mismatch repair) localized advanced low rectal adenocarcinoma (tumor's lower edge ≤ 10 cm from the anus)
- Presence of the following high-risk factors: T3N+/T4/N2/EMVI+/MRF+/lateral lymph node metastasis/inability to undergo sphincter-preserving surgery
- Routine chest and abdominal CT scans showing no distant metastasis
- Bone marrow function: Neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet count (PLT) ≥ 100 × 10^9/L, hemoglobin (Hb) ≥ 70 g/L
- Liver function: ALT, AST ≤ 2.5 × ULN (upper limit of normal); total bilirubin ≤ 1.5 × ULN; serum albumin ≥ 3 g/dL
- Kidney function: Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance ≥ 60 ml/min (calculated using the Cockcroft-Gault formula)
- For females and patients with reproductive potential, a negative pregnancy test must be done within 72 hours before starting the treatment, and the patient must agree to avoid pregnancy during the study treatment and for 6 months after the treatment. For males with reproductive potential partners, the patient must agree to use adequate medically approved contraception during and for 90 days after the final study treatment
- Patients must agree to receive the study's neoadjuvant chemotherapy regimen and sign an informed consent form
- Patients with a history of other malignancies within the past 5 years (except for cured and non-recurring cancers such as in situ carcinoma, basal cell carcinoma of the skin, etc.)
- Patients with active, uncontrolled bacterial, viral, or fungal infections requiring systemic treatment, defined by persistent signs/symptoms related to infection, which do not improve despite appropriate antibiotics, antiviral treatments, and/or other therapies
- Patients with uncontrolled systemic diseases, including unstable angina, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmia, history of severe pericardial disease, or other cardiovascular diseases; uncontrolled hypertension (defined as systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg despite appropriate antihypertensive treatment), or a history of hypertensive crisis, hypertensive encephalopathy; uncontrolled diabetes (fasting blood glucose ≥ 10 mmol/L), etc.
- Patients known to be allergic or intolerant to the treatment drugs or excipients used in this study
- Any clinical indicators showing contraindications to chemotherapy and surgery
- Patients using strong inhibitors or inducers of enzymes such as CYP3A4, CYP2C8, and UGT1A1
- Pregnant or breastfeeding women, and female patients of reproductive potential who refuse to use appropriate contraceptive measures during the study
- Patients who participated in other clinical trials within 4 weeks before enrollment
- Patients whom the investigator deems unsuitable for participation in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Liposomal Irinotecan Liposomal Irinotecan Treatment regimen: 1. During radiotherapy: Radiotherapy 50Gy/25F + liposomal irinotecan 30mg/m² ivgtt qw w1-w4 + capecitabine 625mg/m² Bid, orally on radiotherapy days + tislelizumab 200mg ivgtt q3w; 2. Radiotherapy-surgery interval: Liposomal irinotecan 70mg/m² ivgtt q3w + capecitabine 1000mg/m² Bid D1-D14 q3w + tislelizumab 200mg ivgtt q3w.
- Primary Outcome Measures
Name Time Method Complete remission rate 24 months Complete Remission Rate (CRR) refers to the percentage of patients who have achieved complete remission (CR) after treatment, typically in the context of cancer therapy. Complete remission means that all signs of cancer have disappeared, as determined by clinical, radiological, or pathological evaluation. However, this does not necessarily imply that the disease is cured, as microscopic cancer cells may still be present in the body and the patient may be at risk of relapse. CRR is an important measure used to assess the effectiveness of a treatment regimen, especially in clinical trials and cancer treatment protocols.The complete remission rate includes both pathological complete remission rate and clinical complete remission rate.
- Secondary Outcome Measures
Name Time Method Major Pathological Remission Rate 24 months Major Pathological Remission Rate (MPRR) refers to the percentage of patients who achieve a significant reduction or near-total absence of tumor cells in pathological examination after receiving treatment. The threshold for defining "major" refers to a large proportion (e.g., ≥ 90%) of the tumor being eliminated or showing no viable malignant cells in the pathology report.
Trial Locations
- Locations (1)
Shantou University Medical College Cancer Hospital
🇨🇳Shantou, Guangdong, China
Shantou University Medical College Cancer Hospital🇨🇳Shantou, Guangdong, China