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

13 september 2026 bijgewerkt door: Huang Jinhua, Sun Yat-sen University

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

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Metachronous metastasis is defined as distant metastasis detected at least 6 months after curative treatment of the primary nasopharyngeal tumor. Eligible participants are randomized 1:1 to local ablation plus systemic therapy or systemic therapy alone.

Ablation is performed under CT guidance by two interventional radiologists; multiple lesions are treated in up to 3 sessions 3-4 weeks apart, and complete ablation is assessed by contrast-enhanced CT or PET/CT 3-4 weeks after ablation.

Systemic therapy in both arms consists of gemcitabine 1000 mg/m2 on days 1 and 8 plus cisplatin 80 mg/m2 on day 1 with a PD-1 inhibitor on day 1 every 3 weeks for 6 cycles, followed by PD-1 inhibitor maintenance every 3 weeks for up to 2 years. Tumor response is assessed per RECIST 1.1 every 8 weeks. Adverse events are graded per NCI CTCAE v5.0.

The sample size of 138 (69 per arm) provides 80% power at a two-sided alpha of 0.05 to detect an improvement in objective response rate from 70% to 90%, allowing for 10% dropout.

Studietype

Ingrijpend

Inschrijving (Geschat)

138

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Local ablation plus systemic therapy
CT-guided percutaneous local ablation of all liver and/or lung oligometastases (single lesion in one session; multiple lesions in up to 3 sessions, 3-4 weeks apart), followed by gemcitabine plus cisplatin with a PD-1 inhibitor every 3 weeks for 6 cycles, then PD-1 inhibitor maintenance every 3 weeks for up to 2 years.
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.
Geneesmiddel: Gemcitabine
1000 mg/m2 intravenously on days 1 and 8 of each 21-day cycle for 6 cycles.
Geneesmiddel: Cisplatin
80 mg/m2 intravenously on day 1 of each 21-day cycle for 6 cycles.
Geneesmiddel: 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.
Andere namen:
  • camrelizumab
  • sintilimab
  • tislelizumab
  • toripalimab
Actieve vergelijker: Systemic therapy alone
Gemcitabine plus cisplatin with a PD-1 inhibitor every 3 weeks for 6 cycles, then PD-1 inhibitor maintenance every 3 weeks for up to 2 years.
Geneesmiddel: Gemcitabine
1000 mg/m2 intravenously on days 1 and 8 of each 21-day cycle for 6 cycles.
Geneesmiddel: Cisplatin
80 mg/m2 intravenously on day 1 of each 21-day cycle for 6 cycles.
Geneesmiddel: 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.
Andere namen:
  • camrelizumab
  • sintilimab
  • tislelizumab
  • toripalimab

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator
Tijdsspanne: From randomization until disease progression or end of study treatment, up to approximately 24 months
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).
From randomization until disease progression or end of study treatment, up to approximately 24 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by Investigator
Tijdsspanne: From randomization to progression or death, up to approximately 28 months
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.
From randomization to progression or death, up to approximately 28 months
Overall Survival (OS)
Tijdsspanne: From randomization to death from any cause, up to approximately 28 months
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.
From randomization to death from any cause, up to approximately 28 months
Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by Investigator
Tijdsspanne: From randomization until disease progression or end of study treatment, up to approximately 24 months
Proportion of participants whose best overall response is CR, PR, or stable disease (SD) per RECIST 1.1.
From randomization until disease progression or end of study treatment, up to approximately 24 months
Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator
Tijdsspanne: From first documented response to progression or death, up to approximately 28 months
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.
From first documented response to progression or death, up to approximately 28 months
Incidence of Adverse Events (AEs) Per NCI CTCAE Version 5.0
Tijdsspanne: From first study treatment until 30 days after the last dose of study treatment (or start of new anticancer therapy, whichever first), up to approximately 25 months
Number and proportion of participants with treatment-emergent AEs, serious AEs, and treatment-related AEs, graded per NCI CTCAE v5.0.
From first study treatment until 30 days after the last dose of study treatment (or start of new anticancer therapy, whichever first), up to approximately 25 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Sun Yat-sen University

Onderzoekers

  • Hoofdonderzoeker: Jinhua Huang, MD, Sun Yat-sen University Cancer Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 augustus 2028

Studie voltooiing (Geschat)

1 februari 2029

Studieregistratiedata

Eerst ingediend

13 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

13 september 2026

Eerst geplaatst (Werkelijk)

17 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 september 2026

Laatste update ingediend die voldeed aan QC-criteria

13 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SL-B2025-805-03

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

De-identified individual participant data underlying the results reported in publications will be available to qualified researchers on reasonable request. Human genetic resource data (e.g., sequencing or biomarker data from blood or tissue samples) will be shared only in accordance with the Regulations on the Administration of Human Genetic Resources of the People's Republic of China.

IPD-tijdsbestek voor delen

Beginning 6 months and ending 3 years after publication of the primary results.

IPD-toegangscriteria voor delen

Investigators whose proposed use of the data has been approved by the principal investigator, after signing a data use agreement. Requests should be directed to the principal investigator.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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