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Nasopharyngeal CarcinomaPhase 2NCT07824856

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

A Phase 2 study testing CT-guided percutaneous local ablation, Gemcitabine and Cisplatin in people with Nasopharyngeal Carcinoma and Neoplasm Metastasis, run by Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
CT-guided percutaneous local ablation, Gemcitabine and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
1 siteChina
Study dates
Oct 2026to Feb 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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)

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yi-Quan Jiang, MD contact

+86 20 87343272

jiangyq@sysucc.org.cn

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Yi-Quan Jiang, MD, +86 20 87343272, jiangyq@sysucc.org.cn

Other trials in China

About this study

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

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.

Read the detailed description

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.

Being tested
CT-guided percutaneous local ablation, Gemcitabine, Cisplatin, PD-1 inhibitor
Keywords
local ablation, thermal ablation, oligometastases, metachronous metastasis, PD-1 inhibitor, gemcitabine, cisplatin, nasopharyngeal carcinoma
Medical subject headings
Nasopharyngeal Carcinoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CT-guided percutaneous local ablationProcedure or 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.

  • GemcitabineDrug

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

  • CisplatinDrug

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

  • PD-1 inhibitorDrug

    Also called toripalimab, camrelizumab, tislelizumab, sintilimab

    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.

Study groups in NCT07824856
Study groupRoleWhat they receive
Local ablation plus systemic therapyExperimentalCT-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.
Receives: Procedure: CT-guided percutaneous local ablation; Drug: Gemcitabine; Drug: Cisplatin; Drug: PD-1 inhibitor
Systemic therapy aloneActive comparatorGemcitabine 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.
Receives: Drug: Gemcitabine; Drug: Cisplatin; Drug: PD-1 inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (5)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: From first documented response to progression or death, up to approximately 28 months

  5. Incidence of Adverse Events (AEs) Per NCI CTCAE Version 5.0

    Number and proportion of participants with treatment-emergent AEs, serious AEs, and treatment-related AEs, graded per NCI CTCAE v5.0.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionAug 2028 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are randomized 1:1 to local ablation plus systemic therapy or to systemic therapy alone.
Masking
None (open label)
Enrolment
138 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07824856
Sponsor's protocol ID
SL-B2025-805-03
Status last verified
Sep 2026
First submitted
13 Sep 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Pan CC, Wu PH, Yu JR, Li W, Huang ZL, Wang JP, Zhao M. Comparative survival analysis in patients with pulmonary metastases from nasopharyngeal carcinoma treated with radiofrequency ablation. Eur J Radiol. 2012 Apr;81(4):e473-7. doi: 10.1016/j.ejrad.2011.05.037. Epub 2011 Jun 23.

    PubMed 21700408

  • Zhang MX, Liu T, You R, Zou X, Liu YL, Ding X, Duan CY, Xu HS, Liu YP, Jiang R, Wang ZQ, Lin C, Xie YL, Chen SY, Ouyang YF, Xie RQ, Hua YJ, Sun R, Huang PY, Wang SL, Chen MY. Efficacy of local therapy to metastatic foci in nasopharyngeal carcinoma: large-cohort strictly-matched retrospective study. Ther Adv Med Oncol. 2022 Jul 15;14:17588359221112486. doi: 10.1177/17588359221112486. eCollection 2022.

    PubMed 35860835

  • Yang Y, Pan J, Wang H, Zhao Y, Qu S, Chen N, Chen X, Sun Y, He X, Hu C, Lin L, Yu Q, Wang S, Wang G, Lei F, Wen J, Yang K, Lin Z, Guo Y, Chen S, Huang X, Wu Y, Liang L, Chen C, Bai F, Ma X, Zhang Y, Leaw S, Zhang L, Fang W. Tislelizumab plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal cancer: A multicenter phase 3 trial (RATIONALE-309). Cancer Cell. 2023 Jun 12;41(6):1061-1072.e4. doi: 10.1016/j.ccell.2023.04.014. Epub 2023 May 18.

    PubMed 37207654

  • Yang Y, Qu S, Li J, Hu C, Xu M, Li W, Zhou T, Shen L, Wu H, Lang J, Hu G, Luo Z, Fu Z, Qu S, Feng W, Chen X, Lin S, Zhang W, Li X, Sun Y, Lin Z, Lin Q, Lei F, Long J, Hong J, Huang X, Zeng L, Wang P, He X, Zhang B, Yang Q, Zhang X, Zou J, Fang W, Zhang L. Camrelizumab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (CAPTAIN-1st): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2021 Aug;22(8):1162-1174. doi: 10.1016/S1470-2045(21)00302-8. Epub 2021 Jun 23.

    PubMed 34174189

  • Mai HQ, Chen QY, Chen D, Hu C, Yang K, Wen J, Li J, Shi Y, Jin F, Xu R, Pan J, Qu S, Li P, Hu C, Liu YC, Jiang Y, He X, Wang HM, Lim WT, Liao W, He X, Chen X, Wang S, Yuan X, Li Q, Lin X, Jing S, Chen Y, Lu Y, Hsieh CY, Yang MH, Yen CJ, Samol J, Luo X, Wang X, Tang X, Feng H, Yao S, Keegan P, Xu RH. Toripalimab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Carcinoma: The JUPITER-02 Randomized Clinical Trial. JAMA. 2023 Nov 28;330(20):1961-1970. doi: 10.1001/jama.2023.20181.

    PubMed 38015220

  • Mai HQ, Chen QY, Chen D, Hu C, Yang K, Wen J, Li J, Shi YR, Jin F, Xu R, Pan J, Qu S, Li P, Hu C, Liu YC, Jiang Y, He X, Wang HM, Lim WT, Liao W, He X, Chen X, Liu Z, Yuan X, Li Q, Lin X, Jing S, Chen Y, Lu Y, Hsieh CY, Yang MH, Yen CJ, Samol J, Feng H, Yao S, Keegan P, Xu RH. Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial. Nat Med. 2021 Sep;27(9):1536-1543. doi: 10.1038/s41591-021-01444-0. Epub 2021 Aug 2.

    PubMed 34341578

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CT-guided percutaneous local ablation, Gemcitabine and Cisplatin in people with Nasopharyngeal Carcinoma and Neoplasm Metastasis, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yi-Quan Jiang, MD (+86 20 87343272, jiangyq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator (time frame: From randomization until disease progression or end of study treatment, up to approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07824856, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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