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

NCT05771025 | Unknown

• 1 other identifier: GWK-2022-7275
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma; Liver Metastases

Keywords

Nasopharyngeal Carcinoma; Liver Metastases; Hepatectomy; Prognosis

Outcome Measures

Primary Outcomes (1)

• Overall survival time

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

  up to 60 months

Secondary Outcomes (4)

• Intrahepatic recurrence-free survival

  up to 60 months

• Perioperative morbidity rate

  3 months

• Perioperative mortality rate

  1 month

• Unplanned reoperation rate

  1 month

Study Arms (1)

Hepatectomy group

EXPERIMENTAL

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

Interventions

Hepatectomy PROCEDURE

Patients in the hepatectomy group receive liver resection.

Hepatectomy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nasopharyngeal carcinoma liver metastases (NCLM) are diagnosed by pathological confirmation of liver biopsy or imaging findings combined with clinical history.
• ECOG score ≤ 2 points.
• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Lu Wang, M.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Wang, M.D.

CONTACT

8615026922761; drwanglu@126.com

Yun Feng, M.D.

CONTACT

8618017312986; drfengyun@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: March 16, 2023
• Study Start: April 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)