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RecruitingNCT05771025Updated May 19, 2023

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

An interventional study of Hepatectomy in Nasopharyngeal Carcinoma and Liver Metastases, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-05-19.

Sponsored by Fudan University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Nasopharyngeal Carcinoma
  • Liver Metastases

Keywords

  • Nasopharyngeal Carcinoma
  • Liver Metastases
  • Hepatectomy
  • Prognosis
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 55 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureHepatectomy

    Patients in the hepatectomy group receive liver resection.

06

What researchers measure

Primary outcomes

  1. Overall survival time

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

    Time frame: up to 60 months

Secondary outcomes

  1. 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.

    Time frame: up to 60 months

  2. Perioperative morbidity rate

    Refers to the incidence of perioperative complications.

    Time frame: 3 months

  3. Perioperative mortality rate

    Refers to the mortality rate of patients within 30 days after liver resection.

    Time frame: 1 month

  4. Unplanned reoperation rate

    Refers to the unplanned reoperation rate due to various reasons during the same hospitalization.

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, 200032, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — We can share IPD with other researchers under reasonable requests.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05771025
Lead sponsor
Fudan University
Responsible party
Lu Wang, MD, PhD (Professor, Fudan University) — Principal investigator
First posted
Mar 16, 2023
Start date
Apr 1, 2023
Primary completion
Dec 2023 (estimated)
Completion
Dec 2025 (estimated)
Last update
May 19, 2023

Study contacts

Lu Wang, M.D.
Contact
drwanglu@126.com
8615026922761
Yun Feng, M.D.
Contact
drfengyun@163.com
8618017312986
Lu Wang, M.D.
principal investigator · Fudan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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