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- Ensaio Clínico NCT05290194
Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine in the Treatment of Nasopharyngeal Carcinoma
13 de abril de 2022 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
28
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Zhigang MD Liu, PhD
- Número de telefone: 2528888
- E-mail: zhigangliu1983@hotmail.com
Estude backup de contato
- Nome: Zhigang MD Liu, PhD
- Número de telefone: 2528888
- E-mail: liuzhg9@mail.sysu.edu.cn
Locais de estudo
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Guangdong
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Zhuhai, Guangdong, China
- Recrutamento
- Fifth Affilliated Hospital of Sun Yat-sen University
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Contato:
- Zhigang Liu, M.D.
- Número de telefone: +86 18627585860
- E-mail: zhigangliu1983@hotmail.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 70 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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
Outros nomes:
Capecitabine is treated for patients 3-6 weeks after radiotherapy, which combines with PD-1 inhibitor as the maintenance regimen in the trial.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Progress-free survival
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Overall survival
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Incidence of Treatment-Emergent Adverse Events
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Zhigang MD Liu, PhD, Fifth Affilliated Hospital of Sun Yat-sen University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
28 de março de 2022
Conclusão Primária (Antecipado)
1 de dezembro de 2026
Conclusão do estudo (Antecipado)
1 de janeiro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
5 de março de 2022
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de março de 2022
Primeira postagem (Real)
22 de março de 2022
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de abril de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
13 de abril de 2022
Última verificação
1 de abril de 2022
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Neoplasias por Tipo Histológico
- Neoplasias
- Neoplasias por local
- Neoplasias Glandulares e Epiteliais
- Neoplasias faríngeas
- Neoplasias Otorrinolaringológicas
- Neoplasias de Cabeça e Pescoço
- Doenças Nasofaríngeas
- Doenças Faríngeas
- Doenças estomatognáticas
- Doenças Otorrinolaringológicas
- Neoplasias Nasofaríngeas
- Carcinoma
- Carcinoma nasofaringeal
- Mecanismos Moleculares de Ação Farmacológica
- Antimetabólitos, Antineoplásicos
- Antimetabólitos
- Agentes Antineoplásicos
- Capecitabina
- Inibidores de Ponto de Verificação Imunológica
Outros números de identificação do estudo
- ZDWY[2022]LunziNo.(K11-1)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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