RecruitingPhase 2NCT06590259

A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy in the Treatment of CRCLM

A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy Including PD-1 Inhibitor in the Treatment of Colorectal Cancer Liver Metastasis(CRCLM)


Sponsor

Shanghai 6th People's Hospital

Enrollment

20 participants

Start Date

Mar 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this study is to evaluate the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1(programmed death receptor 1) inhibitor for colorectal cancer liver metastasis and furthermore to clarify its application value by comparing preoperative and postoperative immune indicators.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination approach — using multiple types of ablation (procedures that destroy tumors using heat or cold) along with systemic cancer drugs — for people with colorectal cancer that has spread to the liver and cannot be surgically removed. **You may be eligible if...** - You are between 18 and 75 years old - You have colorectal cancer that has spread to the liver and cannot be or was not surgically removed - You have no more than 5 liver tumors, each measuring 3 cm or less - Your first-line treatment has already stopped working - Your liver function and blood counts are within acceptable limits (Child-Pugh A or B) - You are willing to receive immunotherapy (anti-PD-1) as part of your treatment **You may NOT be eligible if...** - Your liver function is severely impaired (Child-Pugh class C) - Your expected survival is less than 3 months - You have major organ failure or active infection - You have uncontrolled fluid buildup in the abdomen (ascites) or severe muscle wasting 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

DEVICEMulti-mode tumor treatment system

All subjects are treated using the multi-mode tumor treatment system (Shanghai MAaGI Medical Technology Co., Ltd), with the treatment procedure conducted according to the temperature control mode for tumor ablation. Complete ablation of intrahepatic lesions is achieved to realize an intrahepatic no-evidence-of-disease (NED) state. For lesions that could not be ablated in a single session, two treatments are performed to achieve NED within the liver.

DRUGSintilimab+mFOLFOX6 or FOLFIRI+bevacizumab or cetuximab

Systemic therapy including PD-1 inhibitor starts on the 7th day after ablation (sintilimab 200 mg IV D1 + mFOLFOX6 or FOLFIRI + bevacizumab or cetuximab (determined according to the subject's first-line chemotherapy regimen), Q3W, chemotherapy for 4-6 cycles. Sintilimab continues until disease progression, not exceeding a maximum of 2 years.)


Locations(1)

Shanghai Sixth People's Hospital

Shanghai, China

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NCT06590259


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