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

NCT06590259 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai 6th People's Hospital

Phase

Phase 2

Started

2024-03-12

Last updated

2024-09-19

Condition(s) studied

Colorectal Cancer Liver Metastasis

Investigational drug(s) / intervention(s)

Multi-mode tumor treatment systemSintilimab+mFOLFOX6 or FOLFIRI+bevacizumab or cetuximabAll Sintilimab trials (218) →All MFOLFOX6 trials (35) →All Folfox trials (108) →All Bevacizumab trials (435) →All Cetuximab trials (162) →

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.

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.）

Study 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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. Age 18-75 years, gender not specified; 2. Pathologically or clinically confirmed colorectal cancer liver metastases, with liver lesions unsuitable for surgical resection or intolerance or refusal of surgical resection; 3. In the case of an unresectable primary tumor or recurrence, the absence of serious complications such as bleeding or obstruction; 4. Failure of first-line treatment, with disease progression or new liver metastases; 5. No more than 5 liver lesions, with single lesion diameter ≤ 3cm; 6. For those who have received previous chemotherapy, radiotherapy or local liver treatment, the interval from the last systemic treatment or local liver treatment should be at least 1 month; 7. Child-Pugh A or B; bilirubin ≤ 3.0 mg/dL, creatinine ≤ 2.5 mg/dL, white blood cell count ≥ 2.0 ×10\^9/L, platelets ≥ 100 ×10\^9/L; 8. ECOG PS ≤ 2; 9. Willing to accept subsequent treatment regimens that include anti-PD-1 monoclonal antibody therapy. Exclusion Criteria: 1. Liver function Child-Pugh class C; 2. Expected survival \< 3 months; 3. Major organ insufficiency or failure; 4. Active infection; 5. Irreversible coagulation disorders; 6. Refractory massive ascites, pleural effusion or cachexia; 7. Unable to cooperate with treatment; 8. Any other factors deemed inappropriate for inclusion or that may affect the subject's participation in the study, as determined by the investigator.

Primary outcome measure(s)

Progression Free Survival (PFS) — max 24 months
Progression free survival (PFS) is defined as the time from the start of treatment until the criteria for documented progression of disease (or until death due to any cause) are met, whichever comes first according to RECIST 1.1.

Trial sites (1)

Facility	City	Region	Status
Shanghai Sixth People's Hospital	Shanghai	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06590259 on ClinicalTrials.gov ↗ ← All trials in China