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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05771025
• Other study ID #: GWK-2022-7275
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: May 2023
• Source: Fudan University
• Contact: Lu Wang, M.D.
• Phone: 8615026922761
• Email: drwanglu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 2025
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Liver Metastases
• Liver Neoplasms
• Nasopharyngeal Carcinoma
• Neoplasm Metastasis

Intervention

Procedure:
• Hepatectomy
Patients in the hepatectomy group receive liver resection.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival time	Refers to the time from liver resection to death from any cause.	up to 60 months
Secondary	Intrahepatic recurrence-free survival	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.	up to 60 months
Secondary	Perioperative morbidity rate	Refers to the incidence of perioperative complications.	3 months
Secondary	Perioperative mortality rate	Refers to the mortality rate of patients within 30 days after liver resection.	1 month
Secondary	Unplanned reoperation rate	Refers to the unplanned reoperation rate due to various reasons during the same hospitalization.	1 month