Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer (Neo-Field I)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHebei Medical University Fourth Hospital

About this trial

The purpose of this study is to explore the efficacy and safety of involved-field radiotherapy-TNT combined with PD-1 inhibitors in pMMR locally advanced rectal cancer.

Eligibility criteria

Qualifiers

Age ≥18 years old, male or female;

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;

Pathologic diagnosis of adenocarcinoma of the rectum, definite pMMR type;

Clinical staging of T3-4NanyM0 or T1-2N+M0 (based on AJCC 8th edition staging criteria);

Disqualifiers

Pathologic type is other specific types such as neuroendocrine carcinoma, squamous carcinoma, etc;

Previous radiotherapy, chemotherapy, targeted or immunotherapy for rectal cancer;

Active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis requiring long-term immunosuppressive therapy);

Presence of active infection (e.g. HIV, HBV/HCV viral load positive requiring stabilization on antiretroviral therapy);

Trial design

Treatments tested in this trial

  • Capecitabine
  • Camrelizumab
  • CAPOX
  • Involve-field irradiation
  • Elective nodal irradiation
  • TME surgery

Treatment groups

90 Participants
are divided into 2 treatment groups