Vinorelbine

證據等級: L3 | 預測適應症: 10 個

## 藥師評估報告

Vinorelbine：從非小細胞肺癌到 Ewing 肉瘤

一句話總結

Vinorelbine 原本用於治療非小細胞肺癌和轉移性乳癌。 TxGNN 模型預測它可能對 **Ewing 肉瘤 (Ewing sarcoma)** 有效， 目前有 **4 個臨床試驗**支持這個方向。

快速總覽

項目 內容
原適應症 非小細胞肺癌、轉移性乳癌
預測新適應症 Ewing sarcoma、fibromatosis, gingival、fibroma of lung、lung germ cell tumor、pulmonary sulcus neoplasm、hamartoma of lung、small cell lung carcinoma、lung cancer、lung benign neoplasm、lung hilum carcinoma
TxGNN 預測分數 99.999%
證據等級 L3
台灣上市 已上市
許可證數 19 張
建議決策 Proceed with Guardrails

預測適應症詳細分析

1. Ewing sarcoma L2 100.00% 主要分析

為什麼這個預測合理？

Vinorelbine 是半合成的長春花生物鹼（Vinca alkaloid），透過阻斷微管蛋白聚合抑制有絲分裂。Ewing 肉瘤是一種高度增殖的惡性腫瘤，對微管抑制劑具有敏感性。Vinorelbine 在多項兒童難治性腫瘤的臨床試驗中展現活性，包括 Ewing 肉瘤。

</p>

此預測基於藥物的作用機轉，與現有臨床證據方向一致。

臨床試驗

試驗編號階段狀態人數主要發現
NCT06451302NAACTIVE_NOT_RECRUITING100A Prospective Multicenter Cohort Study of Outcome and Safety Profile of Risk Str...
NCT00003234PHASE2COMPLETED50A Phase II Study of Navelbine (Vinorelbine) In Children With Recurrent Or Refrac...
NCT00180947PHASE2UNKNOWN210Phase II Study of Vinorelbine + Cyclofosfamide Association Among Patients Reache...
NCT05999994PHASE2RECRUITING105CAMPFIRE: Children's and Young Adult Master Protocol for Innovative Pediatric Re...
</details>
2. fibromatosis, gingival L5 99.99%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
3. fibroma of lung L5 99.99%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
4. lung germ cell tumor L2 99.99%

臨床試驗（3 項）

試驗編號階段狀態人數主要發現
NCT02489903PHASE2COMPLETED139A Phase II Study of RRx-001 in Platinum Refractory/Resistant Small Cell Carcinom...
NCT03951142PHASE2UNKNOWN165Imaging Perfusion Restrictions From Extracellular Solid Stress - An Open-label L...
NCT01155258PHASE1COMPLETED19Phase I Clinical Trial of Temsirolimus and Vinorelbine in Advanced Solid Tumors.

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5. pulmonary sulcus neoplasm L4 99.99%

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6. hamartoma of lung L4 99.99%

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7. small cell lung carcinoma L1 99.99%

臨床試驗（50 項）

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NCT03652857PHASE2COMPLETED30the Effectiveness and Safety Study on Apatinib Combined With Vinorelbine Used fo...
NCT00004093PHASE1, PHASE2TERMINATED36A Phase I-II Study of Induction Chemotherapy With Carboplatin and Gemcitabine, F...
NCT02176369PHASE2COMPLETED120Maintenance Metronomic Per OS Navelbine In Advanced NSCLC Patients After Previou...
NCT01203735PHASE1, PHASE2UNKNOWN20Valproic Acid in Combination With Concurrent Chemoradiotherapy Using Vinorelbine...
NCT04648033PHASE1COMPLETED21A Phase I Trial of the Hypoxia Modifier Atovaquone in Combination With Radical C...
NCT00004100PHASE3UNKNOWNN/AGemcitabine and Vinorelbine vs Standard Chemotherapy Containing Cisplatin for St...
NCT01441752PHASE3COMPLETED349State Administration of Traditional Chinese Medicine of Shanghai
NCT00499109PHASE3COMPLETED275Randomized Phase III Multicenter Trial of RRM1 & ERCC1 Directed Customized Chemo...
NCT00026156PHASE2COMPLETED125Phase II Trial of Sequential Vinorelbine and Docetaxel in Advanced Non-Small Cel...
NCT00148291PHASE3COMPLETED180Phase III Study of Docetaxel Vs Vinorelbine in Elderly Patients With Advanced No...
NCT00333294PHASE2COMPLETED50A Phase II Open-Label Multicentre Study Of The Efficacy Of ZD1839 (IRESSA™) In C...
NCT00312819PHASE2, PHASE3COMPLETED60Randomized Phase 2 Trial of Treatment of Advanced Non Small Cell Lung Carcinoma ...
NCT01443078PHASE2COMPLETED42Phase II Trial of Neoadjuvant Platinum-based Chemotherapy for Patients With Rese...
NCT06853678NARECRUITING30Selinexor Combined With Nab-paclitaxel and Adebrelimab as Second-line Treatment ...
NCT00295672PHASE2COMPLETED60Oral Vinorelbine and Cisplatin and Concurrent Radiotherapy After Induction Chemo...
NCT01167530PHASE1UNKNOWN36Study to Evaluate RAD001 in Combination With Radiotherapy in Non-small Cell Lung...
NCT03823625PHASE2UNKNOWN112SQUINT (Squamous Immunotherapy Nivolumab-Ipilimumab Trial): An Open-label, Rando...
NCT00004096PHASE1, PHASE2COMPLETEDN/AA Phase I/II Study of Carboplatin and Navelbine for Advanced Non-Small Cell Lung...
NCT00309998PHASE2COMPLETED50Vinorelbine Plus Bevacizumab as First Line Therapy in Patients ≥ 70 Years of Age...
NCT02805530NACOMPLETED36Radical Treatment of Synchronous Oligometastatic Disease and Primary Tumor in Ad...
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NCT00042315PHASE3TERMINATED490A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of ...
NCT00008333PHASE2COMPLETED59Oral Vinorelbine For The Treatment Of Metastatic Non-Small Cell Lung Cancer In P...
NCT00165334PHASE2COMPLETED53Phase II Trial of Cetuximab Plus Vinorelbine in Previously Untreated Patients > ...
NCT03770299PHASE2WITHDRAWN0A Phase 2 Multi-Center Randomized Trial to Assess Early Intervention With Adjuva...
NCT00686959PHASE3COMPLETED598Phase 3 Study of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidati...
NCT01752517N/AUNKNOWN60A Phase Ⅱ Single-arm Clinical Trial to Investigate the Efficacy and Safety of Vi...
NCT00432562PHASE1COMPLETED31A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion (ANX-530) in ...
NCT01454934PHASE3COMPLETED540A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and...
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NCT03456076PHASE3ACTIVE_NOT_RECRUITING257A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of...
NCT01843647PHASE2UNKNOWN100Randomized, Controlled, Multicenter Study of Neoadjuvant Therapy With Icotinib i...
NCT00003587PHASE2COMPLETED204Randomized Phase II Trial of Carboplatin/Gemcitabine Followed By Paclitaxel or C...
NCT00265694PHASE3UNKNOWNN/AA Randomized Phase III Trial of Vinorelbine Versus Gemcitabine and Carboplatin f...
NCT00002583PHASE3COMPLETED482A Phase III Prospective Randomized Study of Adjuvant Chemotherapy With Vinorelbi...
NCT00620971PHASE2COMPLETED77Sequential Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/B...
NCT06540950PHASE2ACTIVE_NOT_RECRUITING47Study of Oral Vinorelbine Single Drug Concurrent Chemoradiotherapy and Immune-ma...
NCT06310915N/ARECRUITING30This Study is a Pilot Study in Driver-negative Locally Advanced/Late-stage Nonsm...
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NCT02579564PHASE3UNKNOWN134Systemic Chemotherapy Combined With Thoracic Cavity Perfusion of Recombinant Hum...
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NCT00083083PHASE2UNKNOWN250Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Adva...
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NCT01850147PHASE2UNKNOWN50Study of Efficacy and Safety of Sequential Low-dose Sunitinib With Chemotherapy ...
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8. lung benign neoplasm L4 99.99%

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## 台灣上市資訊 | 許可證號 | 品名 | 劑型 | 核准適應症 | |---------|------|------|-----------| | 衛署藥輸字第022215號 | 溫諾平注射液10公絲/公撮 | 注射劑 | 非小細胞肺癌，轉移性乳癌 | | 衛署藥輸字第024268號 | 溫諾平30毫克軟膠囊 | 軟膠囊劑 | 非小細胞肺癌、轉移性乳癌 | | 衛署藥輸字第024269號 | 溫諾平20毫克軟膠囊 | 軟膠囊劑 | 非小細胞肺癌、轉移性乳癌 | | 衛部藥製字第060608號 | 威若賓30毫克軟膠囊 | 軟膠囊劑 | 非小細胞肺癌、轉移性乳癌 | | 衛署藥輸字第025489號 | 維諾拜注射液 | 注射劑 | 非小細胞肺癌、轉移性乳癌 | ## 細胞毒性 | 項目 | 內容 | |------|------| | 細胞毒性分類 | 傳統細胞毒性藥物（Vinca alkaloid） | | 骨髓抑制風險 | 高度（嗜中性白血球減少為劑量限制毒性） | | 致吐性分級 | 低度 | | 監測項目 | CBC（含分類）、肝功能、神經毒性評估 | | 處置防護 | 需依細胞毒性藥物處置規範操作；靜脈注射需注意外滲風險 | ## 安全性考量 ### 重大藥物交互作用（Major） | 交互作用藥物 | 機轉說明 | |-------------|---------| | Clarithromycin | CYP3A4 抑制劑，增加 vinorelbine 血中濃度和毒性 | ### 中度藥物交互作用（Moderate） | 交互作用藥物 | 機轉說明 | |-------------|---------| | Aprepitant | CYP3A4 抑制 | | Dexamethasone | 可能影響代謝 | | Simvastatin | CYP3A4 競爭 | | Rosuvastatin | 藥物轉運體交互作用 | ### 藥物-食物交互作用 (DFI) **葡萄柚** 🟡 Moderate - 影響：CYP3A4 代謝藥物，葡萄柚可能影響代謝 - 建議：化療期間避免葡萄柚 ### 藥物-疾病注意事項 (DDSI)
資料來源：DDInter 2.0（原文內容請參閱該網站）
**Gastrointestinal Diseases** 🟡 Moderate - 應謹慎使用本藥物。需定期監測。可能有致命風險。 **Neuromuscular Diseases** 🟡 Moderate - 需定期監測。可能有嚴重不良反應。出現症狀時應考慮停藥。 **Respiratory Insufficiency** 🟢 Minor - 可能危及生命。 **肝臟疾病** 🟢 Minor - 注意事項：Vinorelbine is extensively metabolized by the liver... **Infections** 🟢 Minor - 本藥物在此情況下禁用。需定期監測。風險包括：骨髓抑制、感染、血栓、貧血。 **Bone Marrow Failure Disorders** 🟢 Minor - 本藥物在此情況下禁用。需定期監測。風險包括：骨髓抑制、出血、感染。 ## 結論與下一步 **決策：Proceed with Guardrails** **理由：** Vinorelbine 在多項兒童腫瘤臨床試驗中顯示對 Ewing 肉瘤具有潛在療效，且作用機轉（微管抑制）對高增殖性腫瘤具有合理的生物學基礎。 **若要推進需要：** - 收集專門針對 Ewing 肉瘤的療效數據 - 確定適當的兒科劑量和給藥方案 - 與現有 Ewing 肉瘤標準治療方案的比較評估 - 骨髓抑制和神經毒性的密切監測計畫 --- ## 相關藥物報告 - [Propantheline](/drugs/propantheline/) - 證據等級 L3 - [Interferon Beta-1B](/drugs/interferon_beta-1b/) - 證據等級 L3 - [Dorzolamide](/drugs/dorzolamide/) - 證據等級 L3 - [Prednisolone](/drugs/prednisolone/) - 證據等級 L3 - [Acitretin](/drugs/acitretin/) - 證據等級 L3 ---
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## 引用本報告 如需引用本報告，請使用以下格式： **APA 格式：** ``` TwTxGNN. (2026). Vinorelbine老藥新用驗證報告. https://twtxgnn.yao.care/drugs/vinorelbine/ ``` **BibTeX 格式：** ```bibtex @misc{twtxgnn_vinorelbine, title = {Vinorelbine老藥新用驗證報告}, author = {TwTxGNN Team}, year = {2026}, url = {https://twtxgnn.yao.care/drugs/vinorelbine/} } ``` ---
免責聲明
本報告僅供學術研究參考，不構成醫療建議。藥物使用請遵循醫師指示，切勿自行調整用藥。任何老藥新用決策需經過完整的臨床驗證與法規審查。

最後審核：2026-02-20 | 審核者：TwTxGNN Research Team

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