Actively Recruiting
Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With SIB-IMRT in the Treatment of Locally Advanced Rectal Cancer
Led by Yong Zhang,MD · Updated on 2023-10-11
48
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the efficacy and safety of tislelizumab combined with simultaneous integrated boost intensity-modulated radiotherapy in treating locally advanced rectal cancer. To explore a new PD-1 inhibitor adjuvant chemotherapy model combined with radiotherapy to treat locally advanced rectal cancer.
CONDITIONS
Official Title
Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With SIB-IMRT in the Treatment of Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years.
- Diagnosed with adenocarcinoma of rectal cancer confirmed by histopathology.
- Locally advanced rectal cancer with T3-4 stage or positive regional lymph nodes and no distant metastasis.
- At least one measurable lesion according to RECIST 1.1.
- ECOG performance status score of 0 to 1.
- Expected survival time of at least 6 months.
- Normal major organ function based on blood counts and biochemical tests meeting specified thresholds.
- Volunteered to participate, signed informed consent, able to comply and cooperate with follow-up.
You will not qualify if you...
- History of other malignant tumors within the past 5 years.
- Allergy or sensitivity to any drugs used in the study protocol.
- Innate or acquired immune deficiency such as HIV infection.
- Active or suspected autoimmune diseases or conditions requiring medical intervention (e.g., interstitial pneumonia, uveitis, hepatitis, asthma requiring bronchodilators).
- Active infections requiring systemic treatment.
- Prior treatment with PD-1, PD-L1, or CTLA-4 antibodies or other immunoregulatory receptor-targeting drugs.
- Unresolved toxic effects above CTCAE grade 1 from previous treatments, except hair loss.
- History of significant cardiovascular events or conditions like myocardial infarction, stroke, unstable angina, heart failure, or deep vein thrombosis.
- Recent untreated wounds, fractures, major surgeries, severe injuries, or ulcers within 4 weeks.
- Pregnant or breastfeeding women.
- Liver or kidney dysfunction.
- History of psychotropic drug abuse or mental disorders interfering with study participation.
- Participation in other drug clinical trials within 4 weeks.
- Serious concomitant diseases judged unsafe for study participation.
- Investigator's judgment that participation is not in the patient's best interest.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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