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임상시험 NCT07188103은(는) 식도 편평 세포암에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Ivonescimab Plus Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Esophageal Squamous Cell Carcinoma 2상 37 면역 요법 전체 생존기간
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 NCT07188103은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 식도 편평 세포암에 대해 진행되며, 2상 중재연구으로 현재 상태는 모집중입니다. 연구는 2025년 7월 1일에 시작되어 37명의 참여자를 모집하고 있습니다. Anhui Provincial Hospital이(가) 진행하며, 2027년 6월 30일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 9월 23일에 갱신되었습니다.
간단한 개요
In the era of immunotherapy, the standard second-line treatment regimen for locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) remains controversial. This prospective, single-center, single-arm phase II clinical study aims to evaluate the efficacy and safety of Ivonescimab combined with short-course hypofractionated radiotherapy as a second-line therapy for patients with locally advanced/metastatic...더 보기
공식 제목
Efficacy and Safety of Ivonescimab Combined With Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma: A Prospective, Single-Center, Single-Arm Phase II Clinical Study
질환명
식도 편평 세포암기타 연구 식별자
- 2025KY-296
NCT 번호
실제 연구 시작일
2025-07-01
최신 업데이트 게시
2025-09-23
예상 연구 완료일
2027-06-30
계획된 등록 인원
37
연구종류
중재연구
단계/상
2상
상태
모집중
키워드
Esophageal cancer
Hypofractionated Radiotherapy
Ivonescimab
Hypofractionated Radiotherapy
Ivonescimab
주요 목적
치료
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Ivonescimab+Radiotherapy Short-course hypofractionated radiotherapy was administered to progressive lesions after first-line treatment, with a prescribed dose of 20 Gy in 5 fractions (95% PTV). The monoclonal antibody was initiated within 1 week after completing the radiotherapy regimen, at a dose of 20 mg/kg. Ivonescimab was administered every three weeks until disease progression, intolerable toxicity, or patient refusal. | Ivonescimab+Radiotherapy Short-course hypofractionated radiotherapy was administered to progressive lesions after first-line treatment, with a prescribed dose of 20 Gy in 5 fractions (95% PTV). The monoclonal antibody was initiated within 1 week after completing the radiotherapy regimen, at a dose of 20 mg/kg. Ivonescimab was administered every three weeks until disease progression, intolerable toxicity, or patient refusal. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
PFS | progression free survival | From date of enrollment until the date of first documented progression (radiologic or clinical), assessed every 8 weeks up to 36 months |
Advese Events | Advese Events | Assessed every 8 weeks up to 36 months from the date of enrollment |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
OS | overall survival | From date of enrollment until the date of death from any cause, assessed up to 36 months |
ORR | Objective Response Rate | From enrollment to the time of the second radiological evaluation |
DOR | Duration of Response | the period from the first assessment of Complete Response (CR) or Partial Response (PR) to the first occurrence of Progressive Disease (PD) or death. |
DCR | Disease Control Rate | From enrollment to the time of second radiological evaluation |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
a. Patients with histologically confirmed esophageal squamous cell carcinoma (ESCC) , aged 18-80 years;
b. Unresectable locally advanced, postoperative recurrent, or metastatic ESCC that has progressed on or is intolerant to first-line systemic therapy. For patients who received definitive concurrent chemoradiotherapy (CCRT) , disease progression during or within 6 months post-treatment is considered first-line treatment failure;
c. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) . All positive regional lymph nodes are counted as a single lesion, while non-regional metastatic lymph nodes are counted per station;
d. Adequate major organ function, defined as:
Hematology:
- Hemoglobin (Hb) ≥ 90 g/L
- White blood cell (WBC) count ≥ 1.5 × 10⁹/L
- Platelet count ≥ 60 × 10⁹/L
Serum biochemistry:
- Albumin ≥ 25 g/L
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 × ULN
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 60 mL/min
Echocardiography:
Left ventricular ejection fraction (LVEF) ≥ 50% (lower limit of normal)
- e. Eastern Cooperative Oncology Group (ECOG) performance status: 0-2;
- f. Expected survival ≥ 3 months;
- g. Voluntarily enrolled, with signed informed consent, and willing to comply with study protocols and follow-up.
- a. Patients with severe organ dysfunction, uncontrolled acute infection, or significant comorbidities;
- b. Patients with vertebral metastases accompanied by spinal cord compression symptoms;
- c. Patients with esophagotracheal or esophagomediastinal fistulas;
- d. Patients with uncontrolled pleural, pericardial, or pelvic effusions requiring repeated drainage;
- e. Patients with esophageal primary/metastatic lesions invading the heart or great vessels, as assessed by the responsible physician, with a risk of life-threatening hemorrhage;
- f. Patients with esophageal primary/metastatic lesions invading the trachea or bronchi, as assessed by the responsible physician, with a risk of esophagotracheal fistula;
- g. Patients not suitable for short-course hypofractionated radiotherapy, as evaluated by the responsible physician;
- h. Pregnant or lactating women;
- i. Patients with mental disorders, or those with a history of psychotropic drug abuse and unable to quit;
- j. Patients who have participated in other drug clinical trials within the past 4 weeks;
- k. Patients or their families who refuse to participate in the study.
Anhui Provincial Hospital연구 대표 연락처
연락처: Huiquan Liu, +86 15005518171, [email protected]
1 1개국에 임상시험 장소
Anhui
Anhui Provincal Hospital, Hefei, Anhui, 230000, China
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