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治験 NCT06149689 (PTCA199-7)（対象：膵腺癌）は募集中です。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。 | ||
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復旦大学mFOLFIRINOX Plus Radiotherapy to Patients With CA19-9-normal Advanced Pancreatic Cancer (PTCA199-7) 第II相・フェーズ2 30
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治験番号 NCT06149689 (PTCA199-7) は 膵腺癌 に関する 治療 の研究で、第II相・フェーズ2 介入研究 臨床試験 です。現在は 募集中 で、2024年1月10日 から開始しています。30 名の参加者 の募集が計画されています。この試験は 復旦大学 によって主導され、2026年10月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年8月7日 です。
概要
The purpose of this study is to evaluate the efficacy of mFOLFIRINOX plus radiotherapy to Patients with CA19-9-normal Advanced Pancreatic Cancer.
詳細説明
Pancreatic adenocarcinoma (PDAC) is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. In 2011, the PRODIGE trial has shown that oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) was associated with a survival advantage but ...もっと見る
公式タイトル
mFOLFIRINOX Plus Radiotherapy to Patients With CA19-9-normal Advanced Pancreatic Cancer
疾患名
膵腺癌刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- PTCA199-7
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mFOLFIRINOX plus radiotherapy Patients with advanced pancreatic adenocarcinoma will receive a modified FOLFIRINOX regimen (oxaliplatin \[70 mg per square meter of body surface area\], irinotecan \[130 mg per square meter\], leucovorin \[200 mg per square meter\], and fluorouracil \[2000 mg per square meter\] every 2 weeks). Four-week chemotherapy is considered as a cycle. Patients will be recommended to receive Intensity-Modulated Radiation Thera...もっと見る | mFOLFIRINOX plus radiotherapy Patients with advanced pancreatic adenocarcinoma will receive a modified FOLFIRINOX regimen (oxaliplatin \[70 mg per square meter of body surface area\], irinotecan \[130 mg per square meter\], leucovorin \[200 mg per square meter\], and fluorouracil \[2000 mg per square meter\] every 2 weeks). Four-week chemotherapy is considered as a cycle. Patients will be recommended to receive Intensity-Modulated Radiation Thera...もっと見る |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Overall survival，OS | OS of subjects from recruiting to the time of death from any cause | At the end of Cycle 1 (each cycle is 21 days) |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
progression-free survival, PFS | PFS of subjects from recruiting to the time of disease progression | At the end of Cycle 1 (each cycle is 21 days) |
objective response rate (ORR) | CR + PR | At the end of Cycle 1 (each cycle is 21 days) |
disease control rate (DCR) | CR + PR + SD | At the end of Cycle 1 (each cycle is 21 days) |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Ability to understand and the willingness to sign a written informed consent document.
- Age ≥ 18 years and ≤ 80 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Histologically or cytologically confirmed advanced pancreas adenocarcinoma.
- Patients who have not received any form of anti-tumor therapy.
- Baseline serum CA19-9 ≤ 37 U/mL, CEA≤ 5.2 ng/mL, and CA125 ≤ 35 U/mL.
- Presence of at least of one measurable lesion in agreement to RECIST criteria.
- The expected survival ≥ 3 months.
- Adequate organ performance based on laboratory blood tests.
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
- Pregnant or nursing women.
- Patients who have received any form of anti-tumor therapy.
- Baseline serum CA19-9 > 37 U/mL, CEA > 5.2 ng/mL, or CA125 > 35 U/mL.
- The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
- Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
- Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.
- Renal insufficiency or dialysis
- Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
- Patients who are allergic to oxaplatin or other chemotherapy drugs.
- Patients who are unwilling or unable to comply with study procedures.
復旦大学責任者
Guopei Luo, 主任研究者, Professor, Fudan University
試験中央連絡先
連絡先: Ying Yang, MD, 86 64175590, [email protected]
連絡先: Guopei Luo, MD, [email protected]
1 1カ国の場所
Shanghai Cancer Center, Shanghai, China
Ying Yang, MD, 連絡先, 86 21 64175590, [email protected]
Guopei Luo, MD, 主任研究者
募集中