Actively Recruiting
Neoadjuvant CIETAI With Concurrent Chemoradiotherapy in Local Advanced Rectal Cancer
Led by Third Military Medical University · Updated on 2023-08-23
90
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To increase the efficacy of neoadjuvant PD-1/PD-1 checkpoint inhibitor in local advanced rectal cancer (LARC), we propose preoperative arterial infusion of Tirellizumab and oxaliplatin followed by tumor artery embolization with concurrent chemoradiotherapy as neoadjuvant regimen for LARC.
CONDITIONS
Official Title
Neoadjuvant CIETAI With Concurrent Chemoradiotherapy in Local Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with locally advanced rectal cancer: stage T3/4NanyM0 or T1-2N+M0.
- Aged between 18 and 75 years.
- No prior chemotherapy or radiation therapy received.
- ECOG performance status score of 0 to 2.
- Adequate organ function confirmed by blood tests within 7 days before registration, including white blood cell count ≥ 4,000/mm3, neutrophil count ≥ 1,500/mm3, hemoglobin ≥ 10 g/dL, platelet count ≥ 100,000/mm3, total bilirubin ≤ 1.5 times upper limit of normal, liver enzymes (AST & ALT) ≤ 1.5 times upper limit of normal, serum creatinine ≤ 1.5 times upper limit of normal or creatinine clearance ≥ 60 ml/min.
- Able to tolerate oral administration of capecitabine.
- Able to understand the study, comply with requirements, and cooperate with follow-up.
You will not qualify if you...
- History of severe allergic reactions to humanized antibodies or fusion proteins.
- Hypersensitivity to components of contrast agents or embolic granules.
- Diagnosed with immune deficiency or receiving systemic immunosuppressive therapy within 14 days before first study treatment, except physiological doses of glucocorticoids (≤10 mg/day prednisone or equivalent).
- Active, known, or suspected autoimmune diseases such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hypothyroidism (except certain controlled conditions).
- Severe pre-existing heart diseases including congestive heart failure, uncontrolled arrhythmias, unstable angina, myocardial infarction, or severe heart valve disease.
- Active hepatitis B or C infection.
- Active tuberculosis infection or history of active tuberculosis within the past year without appropriate treatment.
- Brain metastases with symptoms or symptoms controlled for less than 2 months.
- Major surgery, open biopsy, or significant traumatic injury within 28 days before enrollment.
- Pregnant or lactating females; women of childbearing potential refusing contraception.
- Other malignancies except cured skin basal or squamous cell carcinoma or in situ carcinoma.
- Any bleeding signs or history, non-healing wounds, ulcers, or fractures with significant bleeding events in past 4 weeks.
- Arteriovenous thrombosis events within 6 months.
- Dementia, altered mental status, or mental illness preventing consent or questionnaire completion.
- Other serious concurrent diseases as judged by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China, 400042
Actively Recruiting
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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