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

NCT06590259 | Recruiting Phase 2

• 1 other identifier: 20231124
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer Liver Metastasis

Outcome Measures

Primary Outcomes (1)

• 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.

  max 24 months

Secondary Outcomes (5)

• Local Progression Free Survival (LPFS)

  max 24 months

• Objective Response Rate (ORR)

  max 24 months

• Overall Survival (OS)

  max 24 months

• Rate of adverse events

  max 24 months

• Immune indicator analysis

  max 24 months

Study Arms (1)

Multi-mode thermal ablation combined with systemic therapy including PD-1 inhibitor

EXPERIMENTAL

Multi-mode ablation therapy +systemic therapy including PD-1 inhibitor (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.)

Device: Multi-mode tumor treatment system; Drug: Sintilimab+mFOLFOX6 or FOLFIRI+bevacizumab or cetuximab

Interventions

Multi-mode tumor treatment system DEVICE

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.

Also known as: MTT-P1

Multi-mode thermal ablation combined with systemic therapy including PD-1 inhibitor

Sintilimab+mFOLFOX6 or FOLFIRI+bevacizumab or cetuximab DRUG

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.）

Also known as: Systemic therapy including PD-1 inhibitor

Multi-mode thermal ablation combined with systemic therapy including PD-1 inhibitor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years, gender not specified;
• Pathologically or clinically confirmed colorectal cancer liver metastases, with liver lesions unsuitable for surgical resection or intolerance or refusal of surgical resection;
• In the case of an unresectable primary tumor or recurrence, the absence of serious complications such as bleeding or obstruction;
• Failure of first-line treatment, with disease progression or new liver metastases;
• No more than 5 liver lesions, with single lesion diameter ≤ 3cm;
• 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;
• 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;
• ECOG PS ≤ 2;
• Willing to accept subsequent treatment regimens that include anti-PD-1 monoclonal antibody therapy.

You may not qualify if:

• Liver function Child-Pugh class C;
• Expected survival \< 3 months;
• Major organ insufficiency or failure;
• Active infection;
• Irreversible coagulation disorders;
• Refractory massive ascites, pleural effusion or cachexia;
• Unable to cooperate with treatment;

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Cetuximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Chief physician of Medical Oncology

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chief physician of Medical Oncology

CONTACT

13816067266; ssshenzan@163.com

Chief physician of Medical Oncology

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Medical Oncology

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: September 19, 2024
• Study Start: March 12, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)