Status:
RECRUITING
Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With SIB-IMRT in the Treatment of Locally Advanced Rectal Cancer
Lead Sponsor:
Yong Zhang,MD
Conditions:
Rectal Neoplasms
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
This is a randomized controlled trial (RCT). Patients with T3-4 in the 8th AJCC stage or positive regional lymph nodes and no distant metastases will be enrolled. Forty-eight patients will be enrolled...
Eligibility Criteria
Inclusion
- Aged 18 to 70 years.
- The pathological type of rectal cancer diagnosed by histopathology is adenocarcinoma.
- Patients with T3-4 in the eighth AJCC stage or positive regional lymph node and no distant metastasis.
- Having at least one measurable lesion according to RECIST 1.1.
- ECOG score 0-1.
- Expected survival time ≥6 months.
- Major organ function is normal, that is, meeting the following criteria: blood routine: HB≥90g/L, ANC≥1.5×109/L, PLT≥80×109/L; Biochemical examination of ALB≥30g/L, TBIL≤1.5 ULN, ALT and AST≤2.5 ULN, plasma Cr≤1.5 ULN or creatinine clearance ≥60 ml/min.
- Subjects volunteered to join the study, signed the informed consent, had good compliance, and cooperated with follow-up.
Exclusion
- Patients have had or currently have other malignant tumors within 5 years.
- Patients allergic or sensitive to any drug in the study protocol.
- Patients innate or acquired immune deficiency (e.g. HIV infection).
- The presence of any active, known or suspected autoimmune disease (such as, but not limited to, interstitial pneumonia, uveitis, enteritis, hepatitis, arthritis, nephritis, hypophysitis, hyperthyroidism, hypothyroidism, etc.); The subject had vitiligo. Subjects with asthma require bronchodilators for medical intervention.
- The presence of active infections requiring systemic treatment.
- The subject has previously received other PD-1 or PD-L1, or CTLA-4 antibody therapy, or other drug therapy targeting immunoregulatory receptor preparations.
- Unrelieved toxic effects above CTCAE grade 1 due to any previous treatment, excluding alopecia.
- Patients with a history of myocardial infarction or stroke, unstable angina pectoris, decompensated heart failure or deep vein thrombosis.
- Patients with long-term untreated wounds or fractures, major surgical operations or severe traumatic injuries, fractures or ulcers within 4 weeks.
- Pregnant or lactating women.
- Patients with liver and kidney dysfunction.
- Patients with a history of abuse of psychotropic drugs and unable to abstain or patients with mental disorders.
- Patients who have participated in clinical trials of other drugs within 4 weeks.
- Patients with concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or affect the patient's completion of the study.
- The investigator judged that participation in this study was not conducive to the maximum benefit of the subjects.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06017583
Start Date
September 1 2023
End Date
August 31 2026
Last Update
October 11 2023
Active Locations (1)
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1
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021