Actively Recruiting
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
Led by Affiliated Cancer Hospital of Shantou University Medical College · Updated on 2025-08-08
59
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, no gender restriction
- ECOG performance status of 0 or 1
- Biopsy-confirmed pMMR locally advanced mid-lower rectal adenocarcinoma with tumor lower edge ≤ 10 cm from the anal verge
- Presence of at least one high-risk factor: T3N+, T4, N2, EMVI+, MRF+, lateral lymph node metastasis, or inability to preserve anal function during surgery
- No distant metastasis on routine chest and abdominal CT scans
- Bone marrow function with ANC ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, hemoglobin ≥ 70 g/L
- Liver function with ALT and AST ≤ 2.5 × upper limit of normal, total bilirubin ≤ 1.5 × upper limit of normal, serum albumin ≥ 3 g/dL
- Kidney function with serum creatinine ≤ 1.5 × upper limit of normal or creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula)
- Negative pregnancy test within 72 hours before treatment start for females and patients with reproductive potential
- Agreement to avoid pregnancy during treatment and for 6 months after treatment for females, and agreement to use medically approved contraception during treatment and for 90 days after for males with reproductive potential partners
- Willingness to receive study neoadjuvant chemotherapy regimen and provide informed consent
You will not qualify if you...
- History of other malignancies within 5 years except cured and non-recurring cancers like in situ carcinoma or basal cell carcinoma of the skin
- Active, uncontrolled bacterial, viral, or fungal infections requiring systemic treatment
- Uncontrolled systemic diseases including unstable angina, recent myocardial infarction, congestive heart failure, severe arrhythmias, severe pericardial disease, uncontrolled hypertension or diabetes
- Known allergy or intolerance to study drugs or excipients
- Clinical contraindications to chemotherapy and surgery
- Use of strong enzyme inhibitors or inducers such as CYP3A4, CYP2C8, and UGT1A1
- Pregnant or breastfeeding women and females of reproductive potential refusing contraception
- Participation in other clinical trials within 4 weeks before enrollment
- Investigator judgment deeming patient unsuitable for study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shantou University Medical College Cancer Hospital
Shantou, Guangdong, China, 515000
Actively Recruiting
Research Team
J
Jiarui Lin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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