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

Phase 2RecruitingNCT06590259

Shanghai 6th People's Hospital20 enrolled

Overview

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.

This is a single-center, single-arm, prospective study to evaluate the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1 inhibitor in the treatment of colorectal cancer liver metastasis. The study includes 20 patients with colorectal cancer liver metastasis that has failed first-line therapy and is unresectable. All patients will receive multi-mode ablation to achieve complete remission of liver lesions followed by systemic therapy including PD-1 inhibitor. This study will provide preliminary data 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, which could lead to larger randomized trials.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer Liver Metastasis

Interventions

Multi-mode tumor treatment systemDEVICE

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 cetuximabDRUG

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.）

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Sixth People's Hospital

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

Progression Free Survival (PFS)

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.

Time frame: max 24 months

Secondary Outcomes

Local Progression Free Survival (LPFS)

Local progression-free survival (LPFS) is defined as the time from the start of treatment until documented local progression of the lesion(s) under assessment, or until death from any cause, whichever comes first according to RECIST 1.1.

Time frame: max 24 months

Objective Response Rate (ORR)

Objective response rate (ORR) is defined as the proportion of patients with a complete response or partial response to treatment according to RECIST 1.1.

Time frame: max 24 months

Overall Survival (OS)

Overall survival (OS) is defined as the time from the start of treatment until death from any cause.

Time frame: max 24 months

Rate of adverse events

The rate of adverse events will be calculated as the number of participants experiencing any adverse event divided by the total number of participants enrolled in the study.

Time frame: max 24 months

Immune indicator analysis

Immune indicator analysis will be conducted to evaluate the immune status and response of participants to the intervention. This will include the assessment of various immune cell populations and markers, such as: * CD4+ and CD8+ T lymphocyte counts and ratios. * Natural Killer (NK) cell activity and counts. * B cell counts and subsets. * Dendritic cell (DC) counts and functionality. * Monocyte counts and subsets. * Neutrophil, eosinophil and basophil counts. * Myeloid-derived suppressor cell (MDSC) counts. The analysis will utilize flow cytometry to quantify these immune indicators from blood samples collected at specified time points before, during and after the intervention.

Central Contacts

Chief physician of Medical Oncology

CONTACT

13816067266 ssshenzan@163.com

Chief physician of Medical Oncology

CONTACT

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.