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

ConditionsColorectal Cancer Peritoneal (Metastatic) Cancer FAPI PET

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Radiotherapy followed by immunotherapy and chemotherapy
Combination product
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)
Chemotherapy (control)
Drug
Standard second-line treatment regimen: (XELOX/FOLFOX or XELIRI/FOLFIRI ± bevacizumab/ cetuximab)

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Radiotherapy+Immunotherapy+Standard second-line systemic therapyExperimental treatment 1 intervention

Group B: Standard second-line systemic therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

ORR

After two treatment courses, the tumor shrinkage was evaluated according to the RECIST v1.1 standard. The therapeutic response was classified as PR/CR. Chemotherapy combined with immunotherapy (at the patient's expense) was continued, and it was denied to be stopped.

Time frame

From enrollment to the end of two treatment courses (each cycle is 14 days)

Sponsors and contacts

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Fudan University

Lead sponsor

Source ClinicalTrials.gov

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