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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorYong Zhang,MD

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Tislelizumab
  • Capecitabine
  • Oxaliplatin
  • SIB-IMRT
  • IMRT

Treatment groups

48 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Yong Zhang,MD

Lead sponsor

First Affiliated Hospital of Guangxi Medical University

Sponsor institution