Microwave Ablation Combined With Chemotherapy for Colorectal Liver Metastases： a Multicenter Cohort Study

NCT04562727 | Not Yet Recruiting DMC

• 1 other identifier: S2020-266-01
• Study Type: interventional
• Target: 668
• Locations: 0 countries
• Sites: N/A

Brief Summary

Colorectal cancer is the second deadliest malignant tumor worldwide, and liver is the most common site of hematogenic metastasis of Colorectal cancer. Surgery is an effective treatment for colorectal cancer with liver metastasis, however, only 10%-20% of patients with liver metastasis are feasible for radical surgical resection. Many single-center retrospective studies have demonstrated that thermal ablation for liver metastases is comparable to surgery. Chemotherapy can kill the microscopic cancer foci of the liver. The timing of ablation-related chemotherapeutic administration still needs to be explained. The purpose of this study was to compare the clinical efficacy of thermal ablation or combined with perioperative chemotherapy and postoperative chemotherapy in the treatment of colorectal cancer with liver metastasis.

Conditions

Colorectal Carcinoma; Chemotherapy; Liver Metastases

Keywords

Microwave Ablation; Colorectal liver metastasis

Outcome Measures

Primary Outcomes (1)

• DFS

  From the beginning of randomization to the time of disease recurrence or death due to disease progression

  60 months

Secondary Outcomes (5)

• OS

  60 months

• ORR

  60 months

• LTP

  60 months

• CSS

  60 months

• Tumor reactivity assessment

  60 months

Study Arms (3)

Only MWA

EXPERIMENTAL

Only preform MWA, chemotherapy isn't necessary

Drug: Chemotherapy

MWA combined with perioperative chemotherapy

ACTIVE COMPARATOR

MWA combined with perioperative chemotherapy. Chemotherapy was preformed before MWA and after MWA

Drug: Chemotherapy

MWA combined with postoperative chemotherapy

EXPERIMENTAL

MWA combined with perioperative chemotherapy. Chemotherapy was preformed after MWA

Drug: Chemotherapy

Interventions

Chemotherapy DRUG

perioperative chemotherapy or postoperative chemotherapy

Also known as: preoperative chemotherapy, postoperative chemotherapy

MWA combined with perioperative chemotherapy; MWA combined with postoperative chemotherapy; Only MWA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Aged between 18 and 80, WHO physical status score \< level 2
• \) Histologically confirmed colorectal cancer, liver metastasis (≤4), maximum diameter ≤4cm;
• \) Patients without extrahepatic metastasis;
• \) If the primary tumor has been resected or has metastasized at the same time, the multidisciplinary panel determines that the primary tumor can be resected and resected within one month after ablation;
• \) No other chemotherapy experience except anti-tumor treatment for the primary cancer;
• \) The main organs function normally, that is, they meet the following standards:
• Blood routine examination: HB≥90 g/L; The ANC acuity 1.5 x 109 / L; PLT 60 x 109 / L or higher;
• Biochemical examination: ALB ≥29g/L; ALT and AST \< 3 uln; 1.5 ULN TBIL or less; Creatinine 1.5 or less ULN.

You may not qualify if:

• \) A history of other malignant tumors in the past 5 years;
• \) Cardiovascular diseases with significant clinical symptoms (uncontrolled congestive heart failure, angina pectoris, hypertension, arrhythmia);
• \) Persons with coagulation disorders;
• \) Combined with active infection;
• \) Those with any contraindications related to chemotherapy;
• \) Pregnant or lactating women;
• \) A history of substance abuse and mental illness;

Sponsors & Collaborators

• Ping Liang: lead

Related Publications (1)

• Li J, Pang C, Liu G, Xie X, Zhang DZ, Li K, Li Z, He G, Xu E, Zhong H, Yang H, Lu M, Lou K, Xie X, Lan S, Li Q, Dai G, Yu J, Liang P. Thermal ablation with and without adjuvant systemic therapy: a nationwide multicenter observational cohort study of solitary colorectal liver metastases. Int J Surg. 2024 Jul 1;110(7):4240-4248. doi: 10.1097/JS9.0000000000001397.

  PMID: 38597399 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Ping Liang, Doctor

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jianming Li, Dr

CONTACT

860118810611944; lijianming@ccmu.edu.cn

Ping Liang, Doctor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Interventional ultrasound department

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: September 24, 2020
• Study Start: March 1, 2021
• Primary Completion: August 1, 2022
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share