Local Ablation Plus Systemic Therapy for Metachronous Liver and/or Lung Oligometastases From Nasopharyngeal Carcinoma

This single-center, open-label, randomized phase II trial evaluates whether CT-guided local ablation of liver and/or lung oligometastases, added to systemic therapy, improves the objective response rate compared with systemic therapy alone in patients with metachronous liver and/or lung oligometastases (no more than 5 lesions, each 3 cm or smaller) from nasopharyngeal carcinoma.

Sex

All

Minimum age

18 Years

Maximum age

75 Years

Inclusion Criteria:

* Written informed consent to participate in the trial
* Age 18 to 75 years, any sex
* Histologically or cytologically confirmed nasopharyngeal carcinoma, with clinically diagnosed liver and/or lung metastases
* Primary nasopharyngeal tumor cured after curative treatment, with no lymph node metastasis and no metastases outside the liver and lung (metachronous metastasis: distant metastasis detected at least 6 months after curative treatment of the primary tumor)
* No more than 5 liver and/or lung metastases, each 3 cm or smaller in diameter
* Liver and/or lung metastases amenable to ablation
* ECOG performance status 0 or 1
* Adequate hematologic and organ function: absolute neutrophil count ≥1.5×10\^9/L; hemoglobin ≥70 g/L; platelet count ≥50×10\^9/L; white blood cell count ≥3.0×10\^9/L; serum albumin ≥28 g/L; total bilirubin ≤3.0 mg/dL; AST and ALT ≤5×ULN; serum creatinine ≤1.5×ULN; INR ≤2.3 (without anticoagulant therapy)
* No prior systemic therapy for metastatic disease (e.g., gemcitabine plus cisplatin chemotherapy or PD-1 inhibitor)

Exclusion Criteria:

* History of hypersensitivity or intolerance to any study drug
* Severe hepatic insufficiency, pulmonary fibrosis, or pulmonary hypertension
* Poorly controlled infectious or radiation-induced inflammation around the lesion, skin infection at the puncture site, systemic infection, or fever \>38.5 °C
* Estimated life expectancy less than 3 months
* Poorly controlled malignant pleural effusion
* Clinically significant bleeding within 30 days before study entry
* Uncorrectable coagulopathy or marked hematologic abnormality with evident bleeding tendency
* Severe hepatic, renal, cardiac, pulmonary, or cerebral dysfunction; severe anemia, dehydration, or nutritional/metabolic disturbance that cannot be corrected in the short term; left ventricular ejection fraction \<45%
* History of congenital long QT syndrome, or corrected QT interval \>480 ms (Fridericia)
* Psychiatric disorder in an active episode
* Poorly controlled hypertension: systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg
* Urine protein ≥1 g/24 h (participants with ≥1+ proteinuria on dipstick must have 24-hour urine protein measured); prior organ transplantation
* Anticoagulant and/or antiplatelet therapy (except novel oral anticoagulants such as dabigatran and rivaroxaban) not discontinued for more than 5-7 days before ablation
* Other malignancy within the previous 3 years or concurrently
* Prior gemcitabine plus cisplatin chemotherapy or PD-1 inhibitor therapy
* Any other condition that, in the investigator's judgment, makes the patient unsuitable for the trial

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