임상 레이더 AI | ||
|---|---|---|
임상시험 NCT07196345은(는) 식도 편평세포암, TAS 102, 방사선 요법에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
TAS-102 Plus Radiotherapy in Elderly ESCC 1상, 2상 45 고령자
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07196345은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 식도 편평세포암, TAS 102, 방사선 요법에 대해 진행되며, 1상 2상 중재연구으로 현재 상태는 대상자모집전입니다. 참여 신청은 2025년 9월 25일부터 가능하며, 45명의 참여자를 모집할 예정입니다. Qianfoshan Hospital이(가) 진행하는 이 연구는 2028년 12월 31일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 9월 29일에 갱신되었습니다.
간단한 개요
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...
더 보기공식 제목
Efficacy and Safety of Trifluridine/Tipiracil Combined With Radiotherapy in Elderly Patients With Locally Advanced Esophageal Cancer
질환명
식도 편평세포암TAS 102방사선 요법기타 연구 식별자
- YXLL-KY-2025(055)
NCT 번호
실제 연구 시작일
2025-09-25
최신 업데이트 게시
2025-09-29
예상 연구 완료일
2028-12-31
계획된 등록 인원
45
연구종류
중재연구
단계/상
1상
2상
2상
상태
대상자모집전
주요 목적
치료
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적TAS-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. 방사선 요법 Total dose of 50-60 Gy, delivered in 25-28 fractions, administered Monday through Friday (daily) until the full prescribed dose is achieved. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
참여 도우미
적격성 기준
연령대
노인
최소 연령
65 Years
참여 가능한 성별
전체
- 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 Hospital연구 책임자
Jiandong Zhang, 책임연구자, Director of Department of Radiotherapy, Qianfoshan Hospital
연구 대표 연락처
연락처: Jiandong Zhang, Director of Department of Radiotherapy., +86 0531-89268118, [email protected]
1 1개국에 임상시험 장소
Shandong
The First Affiliated Hospital of Shandong First Medical University, Jinan, Shandong, 250000, China
Jiandong Zhang, Director of Department of Radiotherapy, 연락처, +86 0531-89268118, [email protected]