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

Sponsor

Fudan University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05771025

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma Liver Metastases	Procedure: Hepatectomy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hepatectomy group Patients in the hepatectomy group receive hepatectomy, which could be combined with radiotherapy and chemotherapy for the primary tumor during the perioperative period.	Procedure: Hepatectomy Patients in the hepatectomy group receive liver resection.

Arm

Intervention/Treatment

Experimental: Hepatectomy group

Patients in the hepatectomy group receive hepatectomy, which could be combined with radiotherapy and chemotherapy for the primary tumor during the perioperative period.

Procedure: Hepatectomy

Patients in the hepatectomy group receive liver resection.

Outcome Measures

Primary Outcome Measures

Overall survival time [up to 60 months]
Refers to the time from liver resection to death from any cause.

Secondary Outcome Measures

Intrahepatic recurrence-free survival [up to 60 months]
Refers to the time from the start of liver resection to the date of confirmation of intrahepatic tumor recurrence or death from any cause, whichever is earlier, in patients who underwent hepatectomy.
Perioperative morbidity rate [3 months]
Refers to the incidence of perioperative complications.
Perioperative mortality rate [1 month]
Refers to the mortality rate of patients within 30 days after liver resection.
Unplanned reoperation rate [1 month]
Refers to the unplanned reoperation rate due to various reasons during the same hospitalization.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

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.