Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With SIB-IMRT in the Treatment of Locally Advanced Rectal Cancer

Recruiting now · Phase 3

Conditions studied: Rectal Neoplasms

In brief

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.

Key facts

Study ID

NCT06017583

Run by

Yong Zhang,MD

People needed

48

Starts

2023-09-01

Expected to finish

2026-08-31

Last updated by the study team

2023-10-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (enrolling)

Full record on ClinicalTrials.gov

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