Impact of liver surgery on patients with nasopharyngeal cancer that has spread to the liver
Effect of Hepatectomy on the Prognosis of Patients With Nasopharyngeal Carcinoma Liver Metastases
This study tests whether liver surgery can help people with nasopharyngeal cancer that has spread to the liver live longer and have fewer recurrences compared to those who only get medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05771025 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of hepatectomy on the prognosis of patients suffering from nasopharyngeal carcinoma with liver metastases. The study aims to compare overall survival and recurrence-free survival rates between patients undergoing hepatectomy and those receiving only systemic treatment. By utilizing propensity score matching, researchers will analyze the safety and effectiveness of surgical intervention in this patient population. The goal is to provide insights into how surgical removal of liver lesions may influence patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients with nasopharyngeal carcinoma liver metastases who have stable disease or remission after systemic treatment and are eligible for radical liver resection.
Not a fit: Patients with significant liver dysfunction or those with widespread metastases beyond the liver may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve survival rates and quality of life for patients with nasopharyngeal carcinoma liver metastases.
How similar studies have performed: Previous studies have shown promising results for surgical interventions in metastatic cancers, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Lu Wang, M.D. — Fudan University
- Study coordinator: Lu Wang, M.D.
- Email: drwanglu@126.com
- Phone: 8615026922761
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.