The Role and Safety of Radiofrequency Ablation in Recurrent Liver Metastasis of Colorectal Cancer

NCT06609434 | Not Yet Recruiting

• 1 other identifier: 2024-2-2157
• Study Type: interventional
• Target: 111
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if radiofrequency ablation works to treat recurrent colorectal cancer liver metastases after surgery in adults. It will also learn about the safety of radiofrequency ablation. The main questions it aims to answer are: Is radiofrequency ablation safe and effective in the treatment of recurrent colorectal cancer liver metastases? What medical problems do participants have when treating with radiofrequency ablation? Does radiofrequency ablation enable patients with recurrent colorectal cancer liver metastases to live longer? Researchers will compare systemic therapy combined with radiofrequency ablation to systemic therapy to see if radiofrequency ablation works to treat liver metastases better. Participants will: Receive systemic treatment for colorectal cancer liver metastases. Undergo (or not) radiofrequency ablation for colorectal cancer liver metastases. Visit the hospital once every 3 months for checkups and tests.

Conditions

Colo-rectal Cancer; Liver Metastasis

Keywords

Colo-rectal cancer; Liver Metastasis; radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• liver progression-free survival

  Time from initial treatment to intrahepatic disease progression or patient death

  2 years

Secondary Outcomes (1)

• overall survival

  2 years

Study Arms (2)

systemic therapy

NO INTERVENTION

This arm includes patients with intrahepatic recurrence of colorectal cancer liver metastases who underwent systemic therapy.

systemic therapy combined with radiofrequency ablation

EXPERIMENTAL

This arm includes patients with intrahepatic recurrence of colorectal cancer liver metastases who underwent systemic therapy combined with radiofrequency ablation.

Procedure: Radiofrequency ablation

Interventions

Radiofrequency ablation PROCEDURE

This study is the first to apply radiofrequency ablation to multiple recurrent intrahepatic lesions of colorectal cancer liver metastases.

systemic therapy combined with radiofrequency ablation

Eligibility Criteria

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

You may qualify if:

• Patients with colorectal cancer whose primary lesions have been resected or can be controlled;
• Multiple confined lesions in the liver, the number of which can be defined;
• The liver contains at least 2 lesions suitable for radiofrequency ablation;
• The maximum diameter of the intrahepatic tumor is \<5 cm;
• The location of the hepatic lesion does not show obvious invasion with neighboring organs or large blood vessels;
• No extrahepatic metastases or stable extrahepatic metastases;
• Re-operative hepatic surgical resection is not indicated or refused;
• Ultrasound or ultrasonography can show intrahepatic lesions;
• The patient and his/her family request active treatment;
• Voluntary informed consent;
• Male or female at least 18 years of age;
• Platelet count \>50, 000/mm3 and prothrombin activity \>50%;
• Subjects are willing to return to the study center for study follow-up;
• Life expectancy ≥ 6 months.

You may not qualify if:

• Suffering from, but not limited to, the following serious illnesses: congestive heart failure, myocardial infarction or cerebrovascular accident, or life-threatening cardiac arrhythmia within the last 6 months;
• Pregnancy or lactation. Women of childbearing potential must have a negative serum pregnancy test prior to receiving study treatment;
• Known hypersensitivity to any of the intravenous imaging agents that will be used in the study;
• Have portal or hepatic vein tumor infiltration/cancer embolism;
• Prothrombinogen international normalized ratio \>1.5 times the upper limit of normal (UNL) at the study center;
• Platelet count \<50, 000/mm3, absolute neutrophil count \<1500/mm3, or hemoglobin value \<10.0 g/dL;
• Serum creatinine ≥ 2.5 mg/dL or calculated creatinine clearance (CrCl) ≤ 25.0 ml/min;
• Serum bilirubin \>3.0 mg/dL;
• Serum albumin \<2.8 g/dL;
• Body temperature \>101°F (38.3°C) immediately prior to study treatment;
• Being treated with other investigational drugs;
• Heart failure NYHA functional class III or IV.
• Any other circumstances that the investigator deems inappropriate for enrollment.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Wei Yang, PhD

  Peking University Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Yang, PhD

CONTACT

646 750 9871; 13681408183@163.com

Hong Wang, PhD

CONTACT

wanghongcmu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study was divided into two groups, the interventional group was: systemic therapy combined with radiofrequency therapy, the control group was: systemic therapy alone.

Study Record Dates

• First Submitted: September 21, 2024
• First Posted: September 24, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share