Actively Recruiting
Total Neoadjuvant Treatment ±Immunotherapy for High Risk Locally Advanced Rectal Cancer (TNTi)
Led by Peking University Cancer Hospital & Institute · Updated on 2024-01-29
472
Participants Needed
1
Research Sites
339 weeks
Total Duration
On this page
Sponsors
P
Peking University Cancer Hospital & Institute
Lead Sponsor
B
Beijing Nanjiao Cancer Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to compare the PCR rate between Total Neoadjuvant Treatment ±Immunotherapy in high risk locally advanced rectal cancer. The main questions it aims to answer are: * The PCR rate between the two groups * The 3years DFS between the two groups * Chemoradiotherapy and immunotherapy toxicity * Postoperative complications Participants will receive total neoadjuvant treatment ±immunotherapy followed by surgery. Researchers will compare neoadjuvant treatment ±immunotherapy to see the PCR rate.
CONDITIONS
Official Title
Total Neoadjuvant Treatment ±Immunotherapy for High Risk Locally Advanced Rectal Cancer (TNTi)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- ECOG performance status of 0 or 1
- Pathologically confirmed colorectal adenocarcinoma
- Tumor located 12 cm or less from the anal margin or 8 cm or less from the anorectal junction
- Initial MRI stage showing T4b, or mrN2, or positive mesorectal fascia, or positive extramural vascular invasion, or lateral lymph node metastasis
- No distant metastasis detected
- No prior pelvic radiotherapy
- No prior rectal cancer surgery or chemotherapy
- No systemic infections requiring antibiotics
- No associated immune system diseases
- Blood counts: ANC greater than 1.5 cells/mm3, hemoglobin greater than 9.0 g/dL, platelets greater than 800,000/mm3
- Blood biochemistry within specified limits for bilirubin, AST, ALT
- Serum creatinine within 1.5 times the upper limit of normal and creatinine clearance at least 50 mL/min
- Well-controlled hypertension permitted
- Coagulation tests (INR, aPTT) within specified limits or therapeutic anticoagulation
- Thyroid function tests (FT3, FT4, TSH) with no clinical significance
- Normal cardiac function with left ventricular ejection fraction above 50%
- Signed informed consent and agreement to participate
- Good compliance and willingness for follow-up
- Recommended tumor tissue samples provided prior to enrollment
- Fertile participants agree to use highly effective contraception during and for 12 months after treatment
You will not qualify if you...
- Recurrent rectal cancer
- Microsatellite instability or mismatch repair gene deletion
- Other malignancies within the past 5 years (except treated basal or squamous cell skin cancer)
- Arterial embolic diseases within the past 6 months (e.g., angina, myocardial infarction, stroke)
- Prior anti-tumor or experimental therapies
- Pregnancy or lactation
- Other diseases or mental disorders affecting study participation
- Previous anti-PD-1, anti-PD-L1, anti-PD-L2, or VEGFR TKI therapies
- Major surgery within 4 weeks before study drug or unresolved side effects
- Live vaccination, immunotherapy, or radiotherapy within 2 weeks before study drug
- Hematopoietic stimulating factors within 1 week before study drug
- Known allergy to study drug or components
- Active lung diseases or history of active tuberculosis
- Serious uncontrolled medical conditions including infections, hypertension, diabetes, heart disease, or autoimmune diseases requiring immunosuppressive treatment
- Other severe medical conditions or lab abnormalities increasing study risk or interfering with results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China, 100142
Actively Recruiting
Research Team
W
WU AI WEN, M.D.
CONTACT
D
DONG QIU SHI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here