Effect of Hepatectomy on the Prognosis of Patients With Nasopharyngeal Carcinoma Liver Metastases

Trial Title: Effect of Hepatectomy on the Prognosis of Patients With Nasopharyngeal Carcinoma Liver Metastases

NCT ID: NCT05771025

Condition: Nasopharyngeal Carcinoma
Liver Metastases

Conditions: Official terms:
Carcinoma
Neoplasm Metastasis
Nasopharyngeal Carcinoma
Liver Neoplasms
Carcinoma, Hepatocellular

Conditions: Keywords:
Nasopharyngeal Carcinoma
Liver Metastases
Hepatectomy
Prognosis

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Hepatectomy
Description: Patients in the hepatectomy group receive liver resection.
Arm group label: Hepatectomy group

Summary: The goal of this clinical trial is to learn about hepatectomy on the prognosis of patients with nasopharyngeal carcinoma liver metastases (NCLM). The main questions it aims to answer are: To explore the effect of hepatectomy on the overall survival, recurrence-free survival and other prognostic indicators of patients with NCLM. To explore the impact of hepatectomy on the safety of patients with NCLM. Researchers will compare the prognosis of the patients in the hepatectomy group and the patients with NCLM who were prospectively enrolled in the same institution and received only systemic treatment at the same time by propensity score matching.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Nasopharyngeal carcinoma liver metastases (NCLM) are diagnosed by pathological confirmation of liver biopsy or imaging findings combined with clinical history. - ECOG score ≤ 2 points. - 1. Patients with no recurrence of the primary tumor and oligometastasis in the liver. 2. Patients with multiple metastases (bone) without primary tumor recurrence and liver metastases have stable disease (SD) or partial remission (PR) or complete remission (CR) after systemic treatment except for liver lesions. 3. Patients with primary tumor recurrence and liver metastasis (may be combined with bone metastasis) have SD or PR or CR after systemic treatment except for liver lesions. - Able to perform radical resection of liver lesions. - Good liver function (Child-Pugh grade A liver function, estimated remaining liver volume ≥ 30%). - Blood test, coagulation function, liver and kidney function, electrocardiogram, chest X-ray and other preoperative examinations show no clear contraindications for surgery. - Expected survival ≥ 6 months. - Those who voluntarily participate in this study and signe the informed consent form. Exclusion Criteria: - Younger than 18 or older than 70 years old. - ECOG score > 2 points. - Combined with distant metastasis other than liver and bone. - Disease progression (PD) after systemic treatment of the primary tumor and bone metastases. - The liver lesion cannot be resected by R0. - Insufficient liver reserve function (preoperative liver function Child-Pugh B or C grade and cannot be reduced to A grade in a short time, or estimated remaining liver volume <30%). - Combined with surgical contraindications in the preoperative examination, such as cardiac clinical symptoms or diseases that are not well controlled, abnormal coagulation function with bleeding tendency, or receiving thrombolytic therapy, etc.. - Liver metastases have received local treatment for liver metastases such as interventional and radiofrequency. - Pregnant or lactating women. - History of malignant tumors in other parts, severe mental illness, etc.. - Patients or family members cannot understand the conditions and objectives of this study.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Zip: 200032
Country: China

Status: Recruiting

Contact:
Last name: Lu Wang

Phone: +8618121299357
Email: w.lr@hotmail.com

Start date: April 1, 2023

Completion date: December 2025

Lead sponsor:
Agency: Fudan University
Agency class: Other

Source: Fudan University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05771025