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

PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

March 12, 2024

Primary Completion Date

July 31, 2027

Study Completion Date

December 31, 2027

Conditions
Colorectal Cancer Liver Metastasis
Interventions
DEVICE

Multi-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.

DRUG

Sintilimab+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.)

Trial Locations (1)

Unknown

RECRUITING

Shanghai Sixth People's Hospital, Shanghai

All Listed Sponsors
lead

Shanghai 6th People's Hospital

OTHER