Actively Recruiting
Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With Simultaneous Integrated Boost Intensity-modulated Radiotherapy in the Treatment of Locally Advanced Rectal Cancer
Led by Yong Zhang,MD · Updated on 2023-10-11
48
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining tislelizumab, a PD-1 inhibitor, with simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) for treating locally advanced rectal cancer. This randomized controlled trial includes patients with stage T3-4 rectal cancer or positive regional lymph nodes without distant metastases, aiming to explore a new adjuvant chemotherapy model using PD-1 inhibitors alongside radiotherapy. Participants are randomly assigned to two groups. The experimental group receives concurrent SIB-IMRT radiotherapy with capecitabine chemotherapy, completes 2 to 4 cycles of XELOX chemotherapy, and receives intravenous tislelizumab every 21 days for at least 4 cycles. The control group receives standard intensity-modulated radiotherapy (IMRT) without tislelizumab, combined with the same chemotherapy regimens. During the study, tumor size is assessed by MRI or CT imaging, and side effects are carefully recorded. The main outcome measured is the complete response rate between 12 and 18 weeks after treatment. Secondary outcomes include monitoring side effects over 6 months and 3 years, as well as overall survival and disease-free survival over 3 years. Participation includes regular treatment cycles and follow-up evaluations to assess both safety and effectiveness up to three years after treatment begins.
CONDITIONS
Brief 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 rectal adenocarcinoma confirmed by histopathology.
- Stage T3-4 in the eighth AJCC or positive regional lymph nodes without distant metastasis.
- At least one measurable lesion according to RECIST 1.1.
- ECOG performance status score of 0 or 1.
- Expected survival time of at least 6 months.
- Normal major organ function meeting specified blood and biochemical criteria.
- Volunteered and signed informed consent with good compliance and willingness to follow up.
You will not qualify if you...
- History of other malignant tumors within 5 years.
- Allergy or sensitivity to any study drugs.
- Innate or acquired immune deficiency such as HIV infection.
- Active or suspected autoimmune diseases or certain other conditions like vitiligo or asthma requiring bronchodilators.
- Active infections requiring systemic treatment.
- Prior treatment with PD-1, PD-L1, CTLA-4 antibodies, or related immunoregulatory drugs.
- Unresolved toxic effects above CTCAE grade 1 from previous treatments, excluding alopecia.
- History of serious heart conditions like myocardial infarction or stroke.
- Recent major surgery, severe injury, or wounds within 4 weeks.
- Pregnant or breastfeeding women.
- Liver or kidney dysfunction.
- History of psychotropic drug abuse or mental disorders affecting participation.
- Participation in other drug clinical trials within 4 weeks.
- Other diseases or conditions judged by investigators to affect safety or study completion.
- Investigator determination that participation is not in the participant's best interest.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 12 weeks (4 cycles of 21 days each for tislelizumab and chemotherapy)
Participants receive neoadjuvant therapy including concurrent radiotherapy and chemotherapy. The experimental group receives simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) with concurrent capecitabine chemotherapy and at least 4 cycles of tislelizumab. The control group receives intensity-modulated radiotherapy (IMRT) without tislelizumab, along with concurrent capecitabine chemotherapy and 2 to 4 cycles of XELOX chemotherapy after radiotherapy.
Weekly visits during radiotherapy and chemotherapy cycles
Duration - Up to 3 years
Participants are monitored for side effects, overall survival, and disease-free survival after treatment completion.
Periodic visits for up to 3 years
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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