計劃書編號BGB-A317-CS01
NCT Number(ClinicalTrials.gov Identfier)NCT07039162
試驗執行中
2024-06-30 - 2029-06-30
Phase II
召募中8
ICD-10C15.9
食道惡性腫瘤
ICD-10Z51.12
來院接受抗腫瘤免疫療法
ICD-9150.9
食道惡性腫瘤
Tislelizumab免疫治療合併誘導放化療及後續轉換手術治療局部晚期不可切除食道鱗狀細胞癌的第二期臨床試驗
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試驗申請者
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試驗委託 / 贊助單位名稱
中國醫藥大學附設醫院
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臨床試驗規模
台灣多中心
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更新日期
2026/06/17
試驗主持人及試驗醫院
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
適應症
不可切除食道鱗狀細胞癌
試驗目的
本研究的目的是評估局部晚期不可切除食道癌患者在誘導免疫放射化療後進行轉化手術後的臨床結果。主要目標是2年整體存活率。次要目標包括病理完全緩解率、轉化手術率、痊癒性切除率、無疾病存活率、無事件存活率、無遠端轉移存活率、整體存活率、無復發生存率、與此研究案中免疫治療、化療、放療和轉換手術相關的不良事件。
藥品名稱
注射劑
主成份
tislelizumab-jsgr
劑型
270
劑量
100MG/10ML
評估指標
2年整體存活率（OS）
主要納入條件
經開刀或切片檢體證實有食道鱗狀上皮細胞癌之患者。
2. 臨床分期為T4，或至少一個因侵犯鄰近器官而無法切除的轉移性區域淋巴結，或電腦斷層掃描證實為M1的淋巴結，例如鎖骨上淋巴結。
3. 20歲以上之成年人
4. 美國東岸癌症臨床研究合作組織（ECOG）體能狀態≦2分
5. 器官功能正常
6. 有生育能力的女性（包括化學性更年期或因其他醫療原因無月經的女性）必須同意從知情同意之時起至最後一次服用研究產品後5個月或更長時間期間採取避孕措施
具有生育能力的女性被定義為月經開始後、未停經且未接受絕育手術（例如子宮切除術、雙側輸卵管結紮術、雙側卵巢切除術）的所有女性。停經後定義為無特殊原因連續閉經?12個月
7. 男性必須同意從研究治療開始至最後一次研究產品後3個月或更長時間內採取避孕措施
8. 患者必須願意必要時接受根除性手術
9. 願意簽署書面受試者同意書且能確實遵守法規以及試驗規範患者有遠端轉移
2. 患者有食道穿孔或食道?管
3. 患者有腫瘤出血
4. 患者有嚴重感染
5. 控制不良之自體免疫疾病
6. 接受全身性免疫抑制治療或慢性類固醇治療（潑尼松Prednisolone每日10毫克以上）
7. 已知人類免疫缺乏病毒或B型肝炎（HBsAg反應性）或丙型病毒感染（抗-HCV陽性）
�蔌t已處於治療且穩定的B型肝炎表面抗原（HBsAg）帶原者可以納入本試驗，其乙肝病毒載量測試(HBV DNA) < 500 IU/mL 或 < 2500 copies/mL。檢測到B型肝炎表面抗原(HBsAg)陽性或乙肝病毒載量測試(HBV DNA)陽性的患者應按照治療方針進行管理。接受抗病毒藥物治療者應已治療超過2週方能進行隨機分派/納入試驗。
�蔌t丙型肝炎病毒(HCV)抗體測試呈陽性且隨後的C型肝炎病毒核酸(HCV RNA)測試呈陰性者符合納入資格。
8. 過去曾接受相關免疫治療，包括針對 T 細胞共同刺激或免疫檢查點路徑
9. 過去 3 年內曾經或併發惡性腫瘤，子宮頸原位癌或基底型皮膚癌除外
10. 在納入試驗案前4週內進行任何重大手術
11. 孕婦或哺乳期婦女，或妊娠試驗呈陽性
12. 主持人評估無法收案。
2. 臨床分期為T4，或至少一個因侵犯鄰近器官而無法切除的轉移性區域淋巴結，或電腦斷層掃描證實為M1的淋巴結，例如鎖骨上淋巴結。
3. 20歲以上之成年人
4. 美國東岸癌症臨床研究合作組織（ECOG）體能狀態≦2分
5. 器官功能正常
6. 有生育能力的女性（包括化學性更年期或因其他醫療原因無月經的女性）必須同意從知情同意之時起至最後一次服用研究產品後5個月或更長時間期間採取避孕措施
具有生育能力的女性被定義為月經開始後、未停經且未接受絕育手術（例如子宮切除術、雙側輸卵管結紮術、雙側卵巢切除術）的所有女性。停經後定義為無特殊原因連續閉經?12個月
7. 男性必須同意從研究治療開始至最後一次研究產品後3個月或更長時間內採取避孕措施
8. 患者必須願意必要時接受根除性手術
9. 願意簽署書面受試者同意書且能確實遵守法規以及試驗規範患者有遠端轉移
2. 患者有食道穿孔或食道?管
3. 患者有腫瘤出血
4. 患者有嚴重感染
5. 控制不良之自體免疫疾病
6. 接受全身性免疫抑制治療或慢性類固醇治療（潑尼松Prednisolone每日10毫克以上）
7. 已知人類免疫缺乏病毒或B型肝炎（HBsAg反應性）或丙型病毒感染（抗-HCV陽性）
�蔌t已處於治療且穩定的B型肝炎表面抗原（HBsAg）帶原者可以納入本試驗，其乙肝病毒載量測試(HBV DNA) < 500 IU/mL 或 < 2500 copies/mL。檢測到B型肝炎表面抗原(HBsAg)陽性或乙肝病毒載量測試(HBV DNA)陽性的患者應按照治療方針進行管理。接受抗病毒藥物治療者應已治療超過2週方能進行隨機分派/納入試驗。
�蔌t丙型肝炎病毒(HCV)抗體測試呈陽性且隨後的C型肝炎病毒核酸(HCV RNA)測試呈陰性者符合納入資格。
8. 過去曾接受相關免疫治療，包括針對 T 細胞共同刺激或免疫檢查點路徑
9. 過去 3 年內曾經或併發惡性腫瘤，子宮頸原位癌或基底型皮膚癌除外
10. 在納入試驗案前4週內進行任何重大手術
11. 孕婦或哺乳期婦女，或妊娠試驗呈陽性
12. 主持人評估無法收案。
主要排除條件
Exclusion Criteria:
Patient has received systemic therapy for advanced ESCC.
Patients had distant metastasis, including liver, lung, bone and brain metastases.
Patients had esophageal perforation or esophageal fistula
Patients had tumor bleeding
Patients had active infection(e.g. tuberculosis).
History or known human immunodeficiency virus.
Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll.
Systemic immunosuppression therapy or chronic systemic steroid therapy (more than 10mg daily of prednisolone)
Known hepatitis B (HBsAg reactive) or C virus infection (positive anti HCV)
Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA < 500 IU/mL or < 2500 copies/mL) can be enrolled. Patients with detectable HBsAg or detectable HBV DNA should be managed per treatment guidelines. Patients receiving antivirals at screening should have been treated for > 2 weeks before randomization/enrollment.
Patients with a positive HCV antibody test followed by a negative HCV RNA test at screening are eligible.
Previous therapy targeting T-cell costimulating or immune-checkpoint pathways
Prior or concurrent malignancies within the last 3 years, with the exception of carcinoma in situ of the cervix, or basal type skin cancer
Any major surgery within 4 weeks before study enrollment.
Pregnant women or nursing mothers, or positive pregnancy tests
Patients had allogeneic stem cell transplantation or organ transplantation.
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including NYHA Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention.
Patients with interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, or acute lung diseases
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
Other patients judged by the investigators be inappropriate as subjects of this study
Patient has received systemic therapy for advanced ESCC.
Patients had distant metastasis, including liver, lung, bone and brain metastases.
Patients had esophageal perforation or esophageal fistula
Patients had tumor bleeding
Patients had active infection(e.g. tuberculosis).
History or known human immunodeficiency virus.
Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll.
Systemic immunosuppression therapy or chronic systemic steroid therapy (more than 10mg daily of prednisolone)
Known hepatitis B (HBsAg reactive) or C virus infection (positive anti HCV)
Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA < 500 IU/mL or < 2500 copies/mL) can be enrolled. Patients with detectable HBsAg or detectable HBV DNA should be managed per treatment guidelines. Patients receiving antivirals at screening should have been treated for > 2 weeks before randomization/enrollment.
Patients with a positive HCV antibody test followed by a negative HCV RNA test at screening are eligible.
Previous therapy targeting T-cell costimulating or immune-checkpoint pathways
Prior or concurrent malignancies within the last 3 years, with the exception of carcinoma in situ of the cervix, or basal type skin cancer
Any major surgery within 4 weeks before study enrollment.
Pregnant women or nursing mothers, or positive pregnancy tests
Patients had allogeneic stem cell transplantation or organ transplantation.
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including NYHA Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention.
Patients with interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, or acute lung diseases
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
Other patients judged by the investigators be inappropriate as subjects of this study
試驗計畫預計收納受試者人數
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台灣人數
45 人
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全球人數
45 人
