RecruitingPhase 2NCT07079462

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

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


Sponsor

Fudan University

Enrollment

40 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination approach for colorectal cancer that has spread to the lining of the abdomen (called peritoneal metastasis). It compares standard second-line chemotherapy alone versus combining it with targeted radiation therapy guided by a special type of imaging scan (68Ga-FAPI PET) and an immunotherapy drug called cadonilimab. **You may be eligible if...** - You are 18 or older and have colorectal cancer confirmed to have spread to the abdominal lining - Your cancer progressed after first-line treatment (but you have NOT received immunotherapy) - You are in good enough health to tolerate treatment (ECOG 0–1) and expected to live at least 6 months - Your blood counts, liver, kidney, and clotting function are within acceptable levels **You may NOT be eligible if...** - You have very low blood counts, uncontrolled high blood pressure, or active bleeding or ulcers - You have significant heart disease, a recent stroke, or blood clots within the past 6 months - You have previously received immunotherapy (anti-PD-1/PD-L1 drugs) - You have active hepatitis B or C - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTRadiotherapy 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)

DRUGChemotherapy (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

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NCT07079462


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