Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07824856
PHASE2

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

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.

Official title: Efficacy and Safety of Local Ablation Combined With Systemic Therapy for Metachronous Hepatic and/or Pulmonary Oligometastases From Nasopharyngeal Carcinoma: A Single-Center, Open-Label, Randomized Controlled Phase II Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

138

Start Date

2026-10

Completion Date

2029-02

Last Updated

2026-09-17

Healthy Volunteers

No

Interventions

PROCEDURE

CT-guided percutaneous local ablation

Percutaneous thermal ablation of each liver and/or lung metastasis under CT guidance, performed by two interventional radiologists. The ablation needle is positioned in the center of the lesion and ablation parameters are set according to lesion size and location; ablation ends when the ablation zone covers the entire tumor with a safety margin. A single lesion is treated in one session; multiple lesions are treated in up to 3 sessions 3-4 weeks apart. Complete ablation is assessed by contrast-enhanced CT or PET/CT 3-4 weeks after ablation. Ablation is scheduled at least 3 weeks apart from chemotherapy.

DRUG

Gemcitabine

1000 mg/m2 intravenously on days 1 and 8 of each 21-day cycle for 6 cycles.

DRUG

Cisplatin

80 mg/m2 intravenously on day 1 of each 21-day cycle for 6 cycles.

DRUG

PD-1 inhibitor

Any PD-1 inhibitor approved by the China NMPA for nasopharyngeal carcinoma, given intravenously at the labeled dose on day 1 of each 21-day cycle: 6 cycles together with chemotherapy, then maintenance every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent, death, or completion of 2 years of treatment.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China