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

ConditionsNasopharyngeal CarcinomaNeoplasm MetastasisLung MetastasesLiver MetastasesOligometastatic DiseaseAblation Techniques
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • CT-guided percutaneous local ablation

    Procedure/Surgery

    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.

  • Gemcitabine

    Drug

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

  • Cisplatin

    Drug

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

  • PD-1 inhibitor

    Drug

    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.

Treatment groups

138 Participants
are divided into 2 treatment groups
Group A: Local ablation plus systemic therapyExperimental treatment 4 interventions
Group B: Systemic therapy aloneActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator

Proportion of participants whose best overall response is complete response (CR) or partial response (PR) per RECIST 1.1. Tumor assessment (CT/MRI or PET/CT) is performed at baseline, after the first ablation, and every 8 weeks (±7 days) thereafter until disease progression, regardless of treatment continuation, and is evaluated by the investigator and by a senior radiologist. Analyzed in the full analysis set (all randomized participants, intention-to-treat).

Time frame
From randomization until disease progression or end of study treatment, up to approximately 24 months

Secondary outcomes

1

Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by Investigator

Time from randomization to the first documented disease progression per RECIST 1.1 (regardless of treatment continuation) or death from any cause, whichever occurs first. Participants without an event are censored at the date of the last tumor assessment. Estimated by the Kaplan-Meier method and compared between arms by log-rank test.

Time frame
From randomization to progression or death, up to approximately 28 months
2

Overall Survival (OS)

Time from randomization to death from any cause. Participants alive at the last follow-up are censored at the date last known alive. Estimated by the Kaplan-Meier method and compared between arms by log-rank test.

Time frame
From randomization to death from any cause, up to approximately 28 months
3

Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by Investigator

Proportion of participants whose best overall response is CR, PR, or stable disease (SD) per RECIST 1.1.

Time frame
From randomization until disease progression or end of study treatment, up to approximately 24 months
4

Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator

Among participants with CR or PR, time from the first documented CR or PR to the first documented disease progression per RECIST 1.1 or death from any cause, whichever occurs first.

Time frame
From first documented response to progression or death, up to approximately 28 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

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