Efficacy and Safety of Retlirafusp Alfa Plus Bevacizumab and Chemotherapy With or Without Short-Course Radiotherapy in Patients With CRCLM

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

Efficacy and safety of retlirafusp alfa combined with bevacizumab and chemotherapy with or without short-course radiotherapy in conversion therapy for advanced colorectal cancer liver metastases: an exploratory study.

Eligibility criteria

Qualifiers

Provide signed written informed consent and voluntarily agree to participate in this study.

Age ≥ 18 years and ≤ 75 years.

Histologically confirmed colorectal adenocarcinoma.

Liver metastasis confirmed by imaging or pathology.

Disqualifiers

Have a history of allergy to monoclonal antibodies, any component of retlirafusp alfa, bevacizumab, capecitabine, oxaliplatin, or other platinum-based agents.

Any anti-tumor therapy including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy.

Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes within 2 weeks prior to the first dose of study drug (at a dose > 10 mg/day prednisone or equivalent). Inhaled or topical corticosteroids, and adrenal replacement therapy at doses > 10 mg/day prednisone or equivalent, are permitted in the absence of active autoimmune disease.

Receipt of live attenuated vaccine within 4 weeks prior to the first dose of study drug.

Trial design

Treatments tested in this trial

  • SCRT
  • Retlirafusp alfa Injection
  • Bevacizumab
  • CAPOX

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators