Clinical trial NCT05771025: 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
Overall status: RECRUITING
Phase: NA
Conditions: Nasopharyngeal Carcinoma
Liver Metastases
Keywords: Nasopharyngeal Carcinoma
Liver Metastases
Hepatectomy
Prognosis
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Overall survival time
timeFrame: up to 60 months
Secondary outcomes:
measure: Intrahepatic recurrence-free survival
timeFrame: up to 60 months
measure: Perioperative morbidity rate
timeFrame: 3 months
measure: Perioperative mortality rate
timeFrame: 1 month
measure: Unplanned reoperation rate
timeFrame: 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Lu Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: