Neoadjuvant chemotherapy with PD-1 inhibitors and advanced radiotherapy for rectal cancer

Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With Simultaneous Integrated Boost Intensity-modulated Radiotherapy in the Treatment of Locally Advanced Rectal Cancer

This study is testing if a new combination of chemotherapy and advanced radiation can help people with locally advanced rectal cancer do better before surgery compared to standard treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Guangxi Medical University (Academic / other)
• Drugs / interventions: tislelizumab, chemotherapy, tirellizumab
• Locations: 1 site (Nanning, Guangxi)
• Trial ID: NCT06017583 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of tislelizumab, a PD-1 inhibitor, combined with simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) in patients with locally advanced rectal cancer. It is a randomized controlled trial involving 48 patients who will be divided into experimental and control groups to receive preoperative neoadjuvant therapy. The experimental group will receive SIB-IMRT along with capecitabine chemotherapy and tislelizumab, while the control group will receive standard IMRT without tislelizumab. The primary outcome is the rate of pathological and clinical complete response, with secondary outcomes including side effects and overall survival rates.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with T3-4 rectal adenocarcinoma and no distant metastases.

Not a fit: Patients with other malignancies, severe allergies to study drugs, or immune deficiencies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with locally advanced rectal cancer.

How similar studies have performed: Other studies have shown promising results with PD-1 inhibitors in cancer treatment, suggesting potential success for this novel combination approach.

Eligibility criteria

Inclusion Criteria:

1. Aged 18 to 70 years.
2. The pathological type of rectal cancer diagnosed by histopathology is adenocarcinoma.
3. Patients with T3-4 in the eighth AJCC stage or positive regional lymph node and no distant metastasis.
4. Having at least one measurable lesion according to RECIST 1.1.
5. ECOG score 0-1.
6. Expected survival time ≥6 months.
7. 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.
8. Subjects volunteered to join the study, signed the informed consent, had good compliance, and cooperated with follow-up.

Exclusion Criteria:

1. Patients have had or currently have other malignant tumors within 5 years.
2. Patients allergic or sensitive to any drug in the study protocol.
3. Patients innate or acquired immune deficiency (e.g. HIV infection).
4. 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.
5. The presence of active infections requiring systemic treatment.
6. The subject has previously received other PD-1 or PD-L1, or CTLA-4 antibody therapy, or other drug therapy targeting immunoregulatory receptor preparations.
7. Unrelieved toxic effects above CTCAE grade 1 due to any previous treatment, excluding alopecia.
8. Patients with a history of myocardial infarction or stroke, unstable angina pectoris, decompensated heart failure or deep vein thrombosis.
9. Patients with long-term untreated wounds or fractures, major surgical operations or severe traumatic injuries, fractures or ulcers within 4 weeks.
10. Pregnant or lactating women.
11. Patients with liver and kidney dysfunction.
12. Patients with a history of abuse of psychotropic drugs and unable to abstain or patients with mental disorders.
13. Patients who have participated in clinical trials of other drugs within 4 weeks.
14. 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.
15. The investigator judged that participation in this study was not conducive to the maximum benefit of the subjects.

Where this trial is running

Nanning, Guangxi

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

Conditions Rectal Neoplasms; Rectal cancer; Tislelizumab; SIB IMRT