Effect of Hepatectomy on the Prognosis of Patients With Nasopharyngeal Carcinoma Liver Metastases
NCT ID: NCT05771025
Last Updated: 2023-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
55 participants
INTERVENTIONAL
2023-04-01
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Hepatectomy
Patients in the hepatectomy group receive liver resection.
Interventions
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Hepatectomy
Patients in the hepatectomy group receive liver resection.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Lu Wang, MD, PhD
Professor
Principal Investigators
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Lu Wang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GWK-2022-7275
Identifier Type: -
Identifier Source: org_study_id
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