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

13. september 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

138

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510060
        • Sun Yat-sen University Cancer Center
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Gemcitabine
1000 mg/m2 intravenously on days 1 and 8 of each 21-day cycle for 6 cycles.
Medicin: Cisplatin
80 mg/m2 intravenously on day 1 of each 21-day cycle for 6 cycles.
Medicin: 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.
Andre navne:
  • camrelizumab
  • sintilimab
  • tislelizumab
  • toripalimab
Aktiv komparator: 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.
Medicin: Gemcitabine
1000 mg/m2 intravenously on days 1 and 8 of each 21-day cycle for 6 cycles.
Medicin: Cisplatin
80 mg/m2 intravenously on day 1 of each 21-day cycle for 6 cycles.
Medicin: 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.
Andre navne:
  • camrelizumab
  • sintilimab
  • tislelizumab
  • toripalimab

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by Investigator
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sun Yat-sen University

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. august 2028

Studieafslutning (Anslået)

1. februar 2029

Datoer for studieregistrering

Først indsendt

13. september 2026

Først indsendt, der opfyldte QC-kriterier

13. september 2026

Først opslået (Faktiske)

17. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SL-B2025-805-03

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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

IPD-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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