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治験 NCT07330583（対象：食道癌）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
Stereotactic Body Radiation Therapy (SBRT) and Immunotherapy for Oligometastatic Esophageal Cancer 第II相・フェーズ2 22 免疫療法
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 NCT07330583 は 治療 の研究で、食道癌 に関するものです。この 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、2026年3月1日 に開始予定です。22 名の参加者 の募集が計画されています。この試験は AHS Cancer Control Alberta によって主導され、2032年3月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年1月9日 です。
概要
Participants in this study will have esophageal cancer that has spread (metastasized) to other parts of the body either at initial diagnosis (synchronous) or after the cancer returned following treatment (recurrent).
In Alberta, the current standard approach for treating esophageal cancer that has metastasized is to first give patients radiation to the main tumor in the esophagus to relieve symptoms. After that, the...
もっと見る公式タイトル
Phase II Single Arm Study to Evaluate Stereotactic Body Radiation Therapy (SBRT) and Immunotherapy for Management of Patients With Oligometastatic Esophageal Cancer
疾患名
食道癌その他の研究識別子
- IIT-0036
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SBRT | Stereotactic body radiation treatment (SBRT) Standard of care 6-9 cycles of chemotherapy and immunotherapy, which will then be followed by stereotactic body radiation treatment to the residual oligometastatic lesion/s. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Progression free survival | Defined as time from enrollment into study to disease progression at any site or death. | From the date of enrollment in the study for up to approximately 2 years and 7 months or death. |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Local recurrence free survival | Defined as time from enrollment into study to disease progression at site of SBRT treatment or death. | From the date of enrollment in the study for up to approximately 2 years and 7 months or death. |
Overall Survival (OS) | Defined as the time from enrollment into study to death due to any cause. | From the date of enrollment until the time of death due to any cause, assessed up to approximately 2 years and 7 months |
Quality of Life (QOL) | To study the Quality of Life as measured by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (v3) | Screening, 1 - 5 days before the start of each chemotherapy cycle (each cycle is 21 days), 14 - 28 days after completion of chemotherapy (chemotherapy is completed in about 4 months), and 3 monthly after SBRT until 2 years post SBRT |
Cancer Specific Survival (CSS) | Defined as the time from time of enrollment into study to death due to the esophageal cancer. | From enrollment until the time of death due to esophageal cancer, assessed up to about 2 years and 7 months. |
Toxicity Assessment | Treatment related toxicity will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5 | 10 - 20 days after screening (if given), 1 - 5 days prior each cycle of chemotherapy (each cycle is 21 days), 14 - 28 days after end of chemotherapy which is about 4 months, 14-28 days after chemotherapy and 3 monthly after SBRT until 2 years post SBRT. |
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
- Age ≥ 18
- Eastern Cooperative Oncology Group performance status ≤ 2.
- Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus.
- Diagnosed with stage IVB disease (according to UICC TNM version 8) with up to five metastatic lesions in up to three organs.
- At least one metastatic lesion amenable to the delivery of SBRT.
- Estimated life expectancy >6 months.
- The function of important organs meet the following requirements: a. white blood cell count (WBC) ≥ 4.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L; b. platelets ≥ 100×109/L; c. hemoglobin ≥ 9g/dL; d. serum albumin ≥ 2.8g/dL; e. total bilirubin ≤ 1.5×ULN, ALT, AST and/or AKP ≤ 2.5×ULN; f. serum creatinine ≤ 1.5×ULN or creatinine clearance rate >60 mL/min;
- Ability to understand the study and sign informed consent.
- Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level > 40 mIU/mL to confirm menopause.
- Patients of childbearing/reproductive potential should use highly effective birth control methods if indicated, as defined by the investigator, up to the period of finishing capecitabine and for 6 months after last dose. A highly effective method of birth control is defined as those that result in low failure rate (i.e., less than 1% per year) when used consistently and correctly. Note: abstinence is acceptable if this is established and preferred contraception for the patient.
- Females must not be breastfeeding while taking capecitabine or within 2 weeks after the last dose.
- Male patients should agree to not donate sperm during the study while taking capecitabine and for 3 months after the last dose.
- Male patients should not father a child while taking capecitabine and for 3 months after the last dose.
- Progression was confirmed after completion of 4 to 6 cycles of standard chemotherapy and anti-PD1 treatment and not amenable to SBRT.
- Known or suspected allergy or hypersensitivity to monoclonal antibodies and the chemotherapeutic drugs: Capecitabine, paclitaxel, or platinum.
- Patients have spinal bone metastases combined with spinal cord compression.
- A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer.
- Patients who cannot tolerate radiotherapy due to severe cardiac, lung, liver, or kidney dysfunction, or hematopoietic disease or cachexia.
- Inability to provide informed consent due to psychological, familial, social, and other factors.
- Female patients who are pregnant or during lactation.
- Active autoimmune diseases, or a history of autoimmune diseases (including but not limited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism) that precludes the use of immunotherapy as decided by the treating medical oncologist, a history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation.
- A history of interstitial lung disease or non-infectious pneumonia; Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay).
AHS Cancer Control Alberta