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RECRUITING
NCT07079462
PHASE2

Comparing 68Ga-FAPI PET-Guided Abdominal Radiotherapy Combined With Second-Line Standard Therapy and Cadonilimab Versus Second-Line Standard Therapy in Colorectal Cancer With Peritoneal Metastasis

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

Main objective: 1\. To compare the objective response rate (ORR) of 68Ga-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 68Ga-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 68Ga-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cabozantinib.

Official title: A Prospective Randomized Controlled Study Comparing 68Ga-FAPI PET-Guided Abdominal Radiotherapy Combined With Second-Line Standard Therapy and Cadonilimab Versus Second-Line Standard Therapy in Colorectal Cancer With Peritoneal Metastasis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-03-01

Completion Date

2028-05-01

Last Updated

2025-12-24

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Radiotherapy followed by immunotherapy and chemotherapy

Radiotherapy: The prescribed dose is 20-25Gy in 5 daily fractions to all or part of the target lesions. Immunotherapy: One week after the completion of radiotherapy, standard chemotherapy with cadonilimab, 6 mg/kg, is administered every two weeks. Standard second-line systemic therapy: Standard second-line systemic therapy: (XELOX/FOLFOX or XELIRI/FOLFIRI ± bevacizumab/cetuximab)

DRUG

Chemotherapy (control)

Standard second-line treatment regimen: (XELOX/FOLFOX or XELIRI/FOLFIRI ± bevacizumab/ cetuximab)

Locations (2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, China