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Trial Title:
A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy in the Treatment of CRCLM
NCT ID:
NCT06590259
Condition:
Colorectal Cancer Liver Metastasis
Conditions: Official terms:
Colorectal Neoplasms
Neoplasm Metastasis
Bevacizumab
Cetuximab
Immune Checkpoint Inhibitors
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Multi-mode tumor treatment system
Description:
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.
Arm group label:
Multi-mode thermal ablation combined with systemic therapy including PD-1 inhibitor
Other name:
MTT-P1
Intervention type:
Drug
Intervention name:
Sintilimab+mFOLFOX6 or FOLFIRI+bevacizumab or cetuximab
Description:
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.）
Arm group label:
Multi-mode thermal ablation combined with systemic therapy including PD-1 inhibitor
Other name:
Systemic therapy including PD-1 inhibitor
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Sixth People's Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Chief of Medical Oncology
Start date:
March 12, 2024
Completion date:
December 2027
Lead sponsor:
Agency:
Shanghai 6th People's Hospital
Agency class:
Other
Source:
Shanghai 6th People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06590259
