- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05290194
Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine in the Treatment of Nasopharyngeal Carcinoma
2022년 4월 13일 업데이트: Zhigang Liu, Fifth Affiliated Hospital, Sun Yat-Sen University
Multi-target Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine Maintenance Therapy Treating Oligometastatic Nasopharyngeal Carcinoma: a Single-arm, Multicenter, Prospective, Open-label Phase II Clinical Trial
This is a single-arm, multicenter, prospective, open-label phase II clinical trial of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy treating oligometastatic nasopharyngeal carcinoma, the main purpose of which is to evaluate the efficacy of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy regimen in treating oligometastatic nasopharyngeal carcinoma.
연구 개요
상태
모병
상세 설명
This is a single-arm, multicenter, prospective, open-label phase II clinical study of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy for oligometastatic nasopharyngeal carcinoma.
Its primary objective is to assess the efficacy, including progression-free survival (PFS), 2-year overall survival (Two-year OS) and progression-free survival (Two-year PFS), overall survival (OS), duration of response (DOR) and safety of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy in treating oligometastatic nasopharyngeal carcinoma.
The secondary objective is to explore the potential genetic biomarkers and clinical therapeutic efficacy evaluation and prediction model of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy regimen in treating oligometastatic nasopharyngeal carcinoma, providing the evidence of the screening of the potential patients benefiting from the regimen of this trial.
연구 유형
중재적
등록 (예상)
28
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Zhigang MD Liu, PhD
- 전화번호: 2528888
- 이메일: zhigangliu1983@hotmail.com
연구 연락처 백업
- 이름: Zhigang MD Liu, PhD
- 전화번호: 2528888
- 이메일: liuzhg9@mail.sysu.edu.cn
연구 장소
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Guangdong
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Zhuhai, Guangdong, 중국
- 모병
- Fifth Affilliated Hospital of Sun Yat-sen University
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연락하다:
- Zhigang Liu, M.D.
- 전화번호: +86 18627585860
- 이메일: zhigangliu1983@hotmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- The patient was histologically or cytologically diagnosed with nasopharyngeal carcinoma;
- The patient was newly diagnosed with metastatic nasopharyngeal carcinoma (AJCC eighth edition), and after 4-6 cycles of gemcitabine plus cisplatin combined with PD-1 monoclonal antibody regimen, the efficacy reached more than stable disease;
- Except for the primary tumor and cervical lymph node metastasis, less than 5 distant organ metastases, and were suitable for SBRT radiotherapy;
- ECOG PS score 0-2 points;
- Aged 18-70 years old;
Major organ function met the following criteria (14 do not allow the use of any blood components and cell growth factor):
- Neutrophil ANC ≥ 2.0 × 10^9/L; platelet count PLT ≥ 100 × 10^9/L; hemoglobin HB ≥ 90 g/L;
- Serum albumin ≥ 28 g/L;
- Alanine aminotransferase ALT, aspartate aminotransferase AST ≤ 2.5 × ULN; if there is liver metastasis, ALT and AST ≤ 5 × ULN;
- Serum creatinine ≤ 1.5 × ULN, Or creatinine clearance ≥ 60 mL/min;
- INR ≤ 1.5 × ULN, and APTT ≤ 1.5 × ULN;
- Life expectancy ≥ 12 weeks;
- The subject who voluntarily joins the study, sign informed consent, and coordinates with follow-up.
Exclusion Criteria:
- Recurrent and metastatic nasopharyngeal carcinoma after initial treatment;
- Patients received previous treatment of primary lesion or metastasis except for the standard first-line regimen (gemcitabine plus cisplatin combined with PD-1 monoclonal antibody regimen), including induction chemotherapy, adjuvant chemotherapy, concurrent chemoradiotherapy, surgery and other treatments;
- Central nervous system metastastic (confirmed or suspected);
- Allergy to PD-1 monoclonal antibody or other PD-1 monoantibody; intolerance or allergy to capecitabine; suffering any disease or extrinsic factors affecting oral drugs;
- Uncontrolled cardiac clinical symptoms or diseases, such as: ① heart failure of NYHA Grade II or higher ; ② unstable angina pectoris; ③ suffering myocardial infarction within 1 year; ④ patients with supraventricular or arrhythmia requiring clinical intervention;
- Severe infection (CTCAE 5.0 ≥ 2) 4 weeks before the first use of study drugs, such as severe pneumonia, bacteremia, infectious complications requiring hospitalization; baseline chest imaging examination suggests the presence of active pulmonary inflammation; symptoms and signs of infection or the need for oral or intravenous antibiotics (excluding the prophylactic use of antibiotics) 2 weeks before the first use of the study drug;
- History of other malignancies within 5 years or at the time,but except for cured cutaneous basal cell carcinoma and cervical carcinoma in situ, breast carcinoma in situ, superficial bladder tumors (Ta, Tis and T1) and papillary thyroid cancer as well as other cancers treated more than 3 years before the start of the study;
Any of the following conditions is met:
- Received any investigational drug before the first use of the study drug;
- Participated in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or interventional clinical study at the follow-up time;
- Required systemic treatments with corticosteroids (the dose higher than the equivalent dose of 10 mg prednisone per day) or other immunosuppressive agents 2 weeks before the first use of the study drug, except for local inflammation and prevention of allergy and nausea and vomiting. In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticotropic hormone replacement at doses greater than 10 mg daily in prednisone efficacy dose are allowed;
- Received anti-tumor vaccines or vaccinated live vaccines 4 weeks before the first dose of study drug;
- Underwent excessive surgery or severe trauma 4 weeks before the first use of study drug;
- Patients had active autoimmune diseases and a history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes) in the past 2 years; patients who did not require any intervention after adulthood are allowed;
- History of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or history of organ transplantation and bone marrow transplantation;
- Patients with active pulmonary tuberculosis infection found by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection 1 year ago but without regular treatment;
- Patients with active hepatitis (HBV ≥ 2000 IU/ml or HBV DNA ≥ 10000/ml), or hepatitis C (hepatitis C antibody positive, and HCV-RNA ≥ 1000/ml);
- Patients with coagulation abnormalities (PT > 16s, APTT > 43s, TT > 21s, Fbg < 2 g/L), bleeding tendency or receiving thrombolytic or anticoagulant therapy; or patients with previous severe bleeding (bleeding > 30ml within 3 months), hemoptysis (bleeding > 5ml within 4 weeks) within 12 months due to thromboembolic events (including stroke events and/or transient ischemic attack);
- Uncontrolled hypertension (systolic blood pressure > 140 mmHg, or diastolic blood pressure > 90 mmHg); coronary heart disease, arrhythmia ≥ grade II (including QTc prolongation, male > 450 ms, female > 470 ms) and heart failure;
- Urine protein ≥ + +, or 24 hour urine protein ≥ 1.0 g;
- Current diarrhea-related diseases (e.g., ulcerative colitis, Crohn's disease, chronic diarrhea, etc.);
- Known history of psychotropic drug abuse, alcoholism and drug abuse; or current history of antiepileptic drug use;
- Pregnant or lactating;
- Patients considered unsuitable for inclusion by the investigator as assessed by the investigator.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Oligometastatic nasopharyngeal carcinoma
Patients included are going to receive radiotherapy, chemotherapy and immunotherapy.
Radiotherapy includes IMRT and SBRT.
IMRT is applied for primary sites and cervical lymph nodes,and SBRT following is applied for oligometastatic sites.
PD-1 inhibitors: during the whole trial, intravenous, Q3W; Capecitabine: 650mg, po, bid, following the radiotherapy for a year.
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Radiotherapy was performed 3-6 weeks after the end of first-line treatment, followed by conventional fractionated radiotherapy of the primary tumor and cervical lymph node metastases, SBRT radiotherapy of distant organ metastases 3-6 weeks later.
Immunotherapy of PD-1 inhibitor is used during the whole time of this trial until subjects were withdrawn from the trial or the trial complete
다른 이름들:
Capecitabine is treated for patients 3-6 weeks after radiotherapy, which combines with PD-1 inhibitor as the maintenance regimen in the trial.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Progress-free survival
기간: 2 years
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The time between enrollment and progression(in any way) or death (for any reason)
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2 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Overall survival
기간: 2years
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Time from randomization to death (for any reason)
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2years
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Duration of response
기간: 2 yaers
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Time from the first evaluation of the tumor as CR or PR to the first evaluation as PD or death from any cause
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2 yaers
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Incidence of Treatment-Emergent Adverse Events
기간: 2 years
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The incidence of adverse events (≥Grade 2,CTCAE V5.0)
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2 years
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Zhigang MD Liu, PhD, Fifth Affilliated Hospital of Sun Yat-sen University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2022년 3월 28일
기본 완료 (예상)
2026년 12월 1일
연구 완료 (예상)
2027년 1월 1일
연구 등록 날짜
최초 제출
2022년 3월 5일
QC 기준을 충족하는 최초 제출
2022년 3월 20일
처음 게시됨 (실제)
2022년 3월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 4월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 4월 13일
마지막으로 확인됨
2022년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ZDWY[2022]LunziNo.(K11-1)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
SBRT radiotherapy + Conventionally fractionated radiotherapy에 대한 임상 시험
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Joris B.W. ElbersErasmus Medical Center; HollandPTC모병두경부 편평 세포 암종 | 방사선 요법 | 양성자 치료 | 저분할 | 면역 체계 억제네덜란드
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Royal Marsden NHS Foundation TrustMerck Sharp & Dohme LLC종료됨
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Institut Investigacio Sanitaria Pere VirgiliInstitut Català d'Oncologia; Hospital Universitario Ramon y Cajal; Hospital Arnau de Vilanova 그리고 다른 협력자들모병