Local Ablation Plus Systemic Therapy for Metachronous Liver and/or Lung Oligometastases From Nasopharyngeal Carcinoma
2026年9月13日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
138
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Yi-Quan Jiang, MD
- 電話番号：+86 20 87343272
- メール：jiangyq@sysucc.org.cn
研究場所
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Guangdong
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Guangzhou、Guangdong、中国、510060
- Sun Yat-sen University Cancer Center
-
コンタクト：
- Yi-Quan Jiang, MD
- 電話番号：+86 20 87343272
- メール：jiangyq@sysucc.org.cn
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
1000 mg/m2 intravenously on days 1 and 8 of each 21-day cycle for 6 cycles.
80 mg/m2 intravenously on day 1 of each 21-day cycle for 6 cycles.
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.
他の名前：
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アクティブコンパレータ：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.
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1000 mg/m2 intravenously on days 1 and 8 of each 21-day cycle for 6 cycles.
80 mg/m2 intravenously on day 1 of each 21-day cycle for 6 cycles.
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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator
時間枠：From randomization until disease progression or end of study treatment, up to approximately 24 months
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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).
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From randomization until disease progression or end of study treatment, up to approximately 24 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by Investigator
時間枠：From randomization to progression or death, up to approximately 28 months
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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.
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From randomization to progression or death, up to approximately 28 months
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Overall Survival (OS)
時間枠：From randomization to death from any cause, up to approximately 28 months
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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.
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From randomization to death from any cause, up to approximately 28 months
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Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by Investigator
時間枠：From randomization until disease progression or end of study treatment, up to approximately 24 months
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Proportion of participants whose best overall response is CR, PR, or stable disease (SD) per RECIST 1.1.
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From randomization until disease progression or end of study treatment, up to approximately 24 months
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Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator
時間枠：From first documented response to progression or death, up to approximately 28 months
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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.
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From first documented response to progression or death, up to approximately 28 months
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Incidence of Adverse Events (AEs) Per NCI CTCAE Version 5.0
時間枠：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
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Number and proportion of participants with treatment-emergent AEs, serious AEs, and treatment-related AEs, graded per NCI CTCAE v5.0.
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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
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Jinhua Huang, MD、Sun Yat-sen University Cancer Center
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2028年8月1日
研究の完了 (推定)
2029年2月1日
試験登録日
最初に提出
2026年9月13日
QC基準を満たした最初の提出物
2026年9月13日
最初の投稿 (実際)
2026年9月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月17日
QC基準を満たした最後の更新が送信されました
2026年9月13日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
- 顎口腔疾患
- 病理学的プロセス
- 部位別新生物
- 新生物
- 組織型別の新生物
- 頭頸部腫瘍
- 新生物、腺および上皮
- 腫瘍性プロセス
- がん
- 耳鼻咽喉科疾患
- 咽頭腫瘍
- 耳鼻咽喉科の新生物
- 上咽頭疾患
- 咽頭疾患
- 上咽頭腫瘍
- 病理学的状態、徴候および症状
- 上咽頭がん
- 新生物転移
- 抗悪性腫瘍剤、免疫
- 抗悪性腫瘍剤
- 薬理作用の分子機構
- 複素環化化合物、1リング
- 複素環化化合物
- 薬理学的行動
- 化学作用と用途
- 治療用途
- 無機化学物質
- 塩素化合物
- 窒素化合物
- デオキシシチジン
- シチジン
- ピリミジンヌクレオシド
- ピリミジン
- プラチナ化合物
- 免疫チェックポイント阻害剤
- ゲムシタビン
- シスプラチン
- トーパリマブ
- カムレリズマブ
- シンリマブ
- ティスレリズマブ
その他の研究ID番号
- SL-B2025-805-03
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
Beginning 6 months and ending 3 years after publication of the primary results.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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