Comparing 18F-FAPI PET-Guided Abdominal Radiotherapy Combined With Second-Line Standard Therapy and Cadonilimab Versus Second-Line Standard Therapy in Colorectal Cancer With Peritoneal Metastasis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

Main objective:

1\. To compare the objective response rate (ORR) of 18F-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cabozantinib and second-line standard treatment in the treatment of peritoneal metastasis of colorectal cancer.

Secondary objectives:

1. To compare the disease control rate (DCR), duration of continuous remission (DoR), progression-free survival (PFS) and overall survival (OS) of 18F-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cabozantinib and second-line standard treatment in the treatment of peritoneal metastasis of colorectal cancer. 2. To evaluate the safety and tolerability of 18F-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cabozantinib.

Eligibility criteria

Qualifiers

1. Age of 18 years or older. 2. Peritoneal metastasis of colorectal cancer confirmed by histological or cytological examination (International Union Against Cancer 8th edition of colorectal cancer staging).

Disqualifiers

1. Absolute neutrophil count (ANC) < 1.5 × 109/L, or platelet count < 100 × 109/L (for patients with liver metastasis, platelet count < 80 × 109/L), or hemoglobin < 9 g/dL; blood transfusion within 2 weeks prior to enrollment is not allowed to meet the inclusion criteria.

Trial design

Treatments tested in this trial

  • Radiotherapy followed by immunotherapy and chemotherapy
  • Chemotherapy (control)

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

2
Fudan University Shanghai Cancer Center200032, ShanghaiShanghai Municipality, China
Fudan University Shanghai Cancer Center Shanghai China

Sponsors and collaborators

Fudan University

Lead sponsor