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治験 NCT07196345（対象：食道扁平上皮癌 (ESCC)、TAS 102、放射線療法）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
TAS-102 Plus Radiotherapy in Elderly ESCC 第I相・フェーズ1, 第II相・フェーズ2 45 高齢者
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07196345 は 治療 の研究で、食道扁平上皮癌 (ESCC)、TAS 102、放射線療法 に関するものです。この 第I相・フェーズ1 第II相・フェーズ2 介入研究 臨床試験 は現在 募集準備中 で、2025年9月25日 に開始予定です。45 名の参加者 の募集が計画されています。この試験は Qianfoshan Hospital によって主導され、2028年12月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月29日 です。
概要
This study is a single-arm, multicenter clinical trial evaluating the efficacy and safety of radiotherapy combined with TAS-102 monotherapy in elderly patients with locally advanced esophageal cancer.
Treatment Phase: The treatment phase is divided into a Phase I stage and a Phase II stage. The Phase I stage aims to explore the maximum tolerated dose (MTD) of TAS-102 in elderly esophageal cancer patients. A total of...
もっと見る公式タイトル
Efficacy and Safety of Trifluridine/Tipiracil Combined With Radiotherapy in Elderly Patients With Locally Advanced Esophageal Cancer
疾患名
食道扁平上皮癌 (ESCC)TAS 102放射線療法その他の研究識別子
- YXLL-KY-2025(055)
NCT番号
開始日
2025-09-25
最終更新日
2025-09-29
終了予定日
2028-12-31
目標参加者数
45
試験の種類
介入研究
治験の相・段階
第I相・フェーズ1
第II相・フェーズ2
第II相・フェーズ2
状況
募集準備中
主目的
治療
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的TAS-102 + Radiotherapy | TAS-102 Administered orally at 35 mg/m²/dose twice daily (morning and evening), in a bi-weekly regimen on Days 1-5. 放射線治療 Total dose of 50-60 Gy, delivered in 25-28 fractions, administered Monday through Friday (daily) until the full prescribed dose is achieved. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
2-years OS rate | The percentage of study participants who are still alive at 2 years after the starting date of the study drug, calculated from the starting date of the study drug to the date of death from any cause. | Approximately 24 months after the last subject participating in |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
ORR | The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first. | Approximately 4 months after the last subject participating in |
PFS | The time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first (per RECIST 1.1). | Approximately 12 months after the last subject participating in |
Adverse Event (AE) | Type, incidence, grading (based on NCI-CTCAE v5.0 criteria), and duration of adverse event. | Up to approximately 2 years |
参加アシスタント
適格基準
対象年齢
高齢者
試験の最低年齢
65 Years
対象性別
全て
- Patients must have newly confirmed histologically or cytologically diagnosed esophageal squamous cell carcinoma.
- Age between 65 and 85 years.
- Esophageal cancer staged as IIB to IVB according to the 8th edition AJCC staging system (including IVB with supraclavicular or celiac lymph node metastasis, but excluding IVB with other distant metastases).
- ECOG performance status of 0 or 1.
- No history of esophageal perforation, active esophageal bleeding, or significant invasion of the trachea or major thoracic blood vessels.
- No prior anticancer therapy such as radiotherapy or chemotherapy. Adequate bone marrow function: hemoglobin ≥9 g/dL, white blood cells ≥3.0×10⁹/L, neutrophils ≥1.5×10⁹/L, platelets ≥100×10⁹/L.
- Adequate liver and kidney function: serum creatinine (Scr) ≤1.5×ULN, total bilirubin ≤1.5×ULN, ALT and AST ≤2.5×ULN.
- No history of interstitial lung disease.
- Forced expiratory volume (FEV1) ≥0.8 liters.
- Signed informed consent form before study initiation.
- Patients with hematogenous metastasis or distant lymph node metastasis (except supraclavicular or celiac lymph node metastasis), multiple esophageal cancer lesions, or malignant pleural/pericardial effusion.
- History of radiotherapy, chemotherapy, or surgery targeting the primary tumor or lymph nodes.
- Tracheoesophageal fistula, invasion of the trachea or main bronchi by the primary tumor, deep esophageal ulcer, or hematemesis.
- Severe comorbidities such as active infection, cardiovascular disease, or pulmonary disease.
- History of other malignancies except adequately treated non-melanoma skin cancer.
- Participation in another clinical trial within the past 30 days.
- Any other condition deemed by the investigator to preclude participation in the study.
Qianfoshan Hospital責任者
Jiandong Zhang, 主任研究者, Director of Department of Radiotherapy, Qianfoshan Hospital
試験中央連絡先
連絡先: Jiandong Zhang, Director of Department of Radiotherapy., +86 0531-89268118, [email protected]
1 1カ国の場所
Shandong
The First Affiliated Hospital of Shandong First Medical University, Jinan, Shandong, 250000, China
Jiandong Zhang, Director of Department of Radiotherapy, 連絡先, +86 0531-89268118, [email protected]