search
Back to results

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

Primary Purpose

Nasopharyngeal Carcinoma, Liver Metastases

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hepatectomy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, Liver Metastases, Hepatectomy, Prognosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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. 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.

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hepatectomy group

Arm Description

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

Outcomes

Primary Outcome Measures

Overall survival time
Refers to the time from liver resection to death from any cause.

Secondary Outcome Measures

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.
Perioperative morbidity rate
Refers to the incidence of perioperative complications.
Perioperative mortality rate
Refers to the mortality rate of patients within 30 days after liver resection.
Unplanned reoperation rate
Refers to the unplanned reoperation rate due to various reasons during the same hospitalization.

Full Information

First Posted
February 6, 2023
Last Updated
May 18, 2023
Sponsor
Fudan University
search

1. Study Identification

Unique Protocol Identification Number
NCT05771025
Brief Title
Effect of Hepatectomy on the Prognosis of Patients With Nasopharyngeal Carcinoma Liver Metastases
Official Title
Effect of Hepatectomy on the Prognosis of Patients With Nasopharyngeal Carcinoma Liver Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma, Liver Metastases
Keywords
Nasopharyngeal Carcinoma, Liver Metastases, Hepatectomy, Prognosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hepatectomy group
Arm Type
Experimental
Arm Description
Patients in the hepatectomy group receive hepatectomy, which could be combined with radiotherapy and chemotherapy for the primary tumor during the perioperative period.
Intervention Type
Procedure
Intervention Name(s)
Hepatectomy
Intervention Description
Patients in the hepatectomy group receive liver resection.
Primary Outcome Measure Information:
Title
Overall survival time
Description
Refers to the time from liver resection to death from any cause.
Time Frame
up to 60 months
Secondary Outcome Measure Information:
Title
Intrahepatic recurrence-free survival
Description
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.
Time Frame
up to 60 months
Title
Perioperative morbidity rate
Description
Refers to the incidence of perioperative complications.
Time Frame
3 months
Title
Perioperative mortality rate
Description
Refers to the mortality rate of patients within 30 days after liver resection.
Time Frame
1 month
Title
Unplanned reoperation rate
Description
Refers to the unplanned reoperation rate due to various reasons during the same hospitalization.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lu Wang, M.D.
Phone
8615026922761
Email
drwanglu@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yun Feng, M.D.
Phone
8618017312986
Email
drfengyun@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lu Wang, M.D.
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Wang
Phone
+8618121299357
Email
w.lr@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We can share IPD with other researchers under reasonable requests.

Learn more about this trial

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

We'll reach out to this number within 24 hrs