Eficácia e segurança do Adebrelimab combinadas com quimiorradioterapia em pacientes com carcinoma de células escamas e esôfagoes e esofágicas e pós -operatórias, carcinoma de células escamosas e pós -operatórias
Um estudo clínico de Fase II sobre a eficácia e a segurança do Adebrelimab combinado com a quimiorradioterapia em pacientes com carcinoma de células escamas e esôfagoes e esofágicas não -operacionais ou pós -operatórias, carcinoma
This study was a multi-center, single-arm, open-label phase II clinical trial. Thirty patients with unresectable locally advanced or postoperative recurrent esophageal squamous cell carcinoma were treated with concurrent chemoradiotherapy combined with immunotherapy. The radiotherapy regimen was intensity-modulated radiotherapy with PGTV at 50-50.4 Gy/25-28 fractions, 1.8-2 Gy per fraction, five times a week. The chemotherapy regimen was paclitaxel 50 mg/m2 and cisplatin 25 mg/m2 intravenous infusion on day 1, once a week for five times. The immunotherapy was with adebutilimab at 1200 mg on day 1, every three weeks for three times. One week before radiotherapy, gastroscopy, chest CT or PET-CT images were taken as the baseline standard. Based on the results of gastroscopy, chest CT or PET-CT before and after treatment, the number of patients with complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) in the two groups was observed. The objective response rate (ORR) was calculated as CR + PR, and the disease control rate (DCR) was calculated as CR + PR + SD. The progression-free survival (PFS), overall survival (OS), 1-year and 2-year survival rates and adverse reactions were also statistically analyzed.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Guangdong
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Guangzhou, Guangdong, China
- Nanfang Hospital, Southern Medical University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age 18-75 years old, gender unlimited
- Esophageal squamous cell carcinoma confirmed by histology and unresectable locally advanced or postoperative recurrence
- According to the solid tumor efficacy evaluation criteria (RECIST1.1), there is at least one measurable lesion; And the lesion had not received prior radiotherapy
- ECOG: 0~1
- Expected survival ≥12 weeks 6. Laboratory examination: neutrophils ≥1.5 x 109/L, platelets ≥100 x 109/L; Hemoglobin ≥ 9g/L; Albumin ≥ 2.8g/dL; Bilirubin ≤1.5 times ULN, ALT and AST≤2.5 times ULN
7: Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up 8: Tissue samples should be provided for biomarker analysis such as (PD-L1). Newly acquired tissues are preferred, and 15 5-6um thick paraffin sections can not be provided for archiving by the recent organizer
Exclusion Criteria:
- Other malignant tumors have been diagnosed within the previous 5 years
- There is distant organ metastasis (according to AJCC stage, supraclavicular lymph node metastasis is M1, which should be excluded)
- Lesions invading the trachea or large blood vessels, or investigators judge that there is a high risk of esophageal/tracheal fistula or bleeding
- Have any history of active autoimmune disease or autoimmune disease
- Have clinical symptoms or diseases of the heart that are not under control
- Active infection or fever (except definite tumor fever)
- History or evidence of interstitial lung disease or active non-infectious pneumonia
- Patients with immune dysfunction and active hepatitis
- Those who have previously received PD-1 or PD-L1 antibody therapy
- Allergic to any drug in this protocol
- Patients receiving immunosuppressive drugs or corticosteroids >10mg/ day of prednisone therapeutic dose within 14 days prior to enrollment
- Patients who had received radiotherapy, chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to enrollment
- Pregnant or lactating women
Plano de estudo
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 |
|---|---|
|
Experimental: Adebrelimab combinado com quimiorradioterapia
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Concurrent Chemoradiotherapy combined with Immunotherapy，including： Radiotherapy: intensity modulated radiotherapy, PGTV 50-50.4Gy/25-28F, 1.8-2Gy/F, 5 times a week; Chemotherapy: paclitaxel 50mg/ m2 + cisplatin 25mg/ m2, intravenous infusion of day1, once a week, a total of 5 times; Adebrelimab: 1200 mg day1, Q3W, 3 times. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Objective response rate at 3 months after radiotherapy (ORR)
Prazo: Three months after radiation
|
ORR includes Complete Response (CR) and Partial Response (PR) according to accepted response evaluation criteria (such as solid tumor RECIST version 1.1), (1) Complete response (CR) : Except for nodular disease, all target lesions disappeared completely. All target nodules must be reduced to normal size (short axis < 10 mm). All target lesions must be evaluated. (2) Partial response (PR) : Total diameter of all measurable target lesions is ≥ 30% below baseline. The short diameter was used for the sum of the target nodules, while the longest diameter was used for the sum of all other target lesions. All target lesions must be evaluated. |
Three months after radiation
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Sobrevivência geral
Prazo: Desde a data do início do tratamento (ou diagnóstico) até a data da morte de qualquer causa, avaliada até 120 meses
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Desde a data do início do tratamento (ou diagnóstico) até a data da morte de qualquer causa, avaliada até 120 meses
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|
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Sobrevivência livre de progressão
Prazo: O tempo desde o início do tratamento até a progressão do tumor ou a morte devido a qualquer causa ， avaliada até 120 meses
|
O tempo desde o início do tratamento até a progressão do tumor ou a morte devido a qualquer causa ， avaliada até 120 meses
|
|
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Clinical complete response rate
Prazo: "Monitored throughout the treatment period and during follow-up, an average of 2 years"
|
Except for nodular disease, all target lesions disappeared completely. All target nodules must be reduced to normal size (short axis < 10 mm). All target lesions must be evaluated |
"Monitored throughout the treatment period and during follow-up, an average of 2 years"
|
|
Quality of life scores of cancer patients
Prazo: "Monitored throughout the treatment period and during follow-up, an average of 2 years
|
Assess the patient's physical function, psychological state, social function, symptom burden, and overall health status through telephone follow-ups, return visits for review, and other methods .The measurement tool is SF-36 Quality of Life Assessment Scale |
"Monitored throughout the treatment period and during follow-up, an average of 2 years
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Neoplasias por local
- Neoplasias
- Neoplasias por Tipo Histológico
- Neoplasias gastrointestinais
- Neoplasias do Aparelho Digestivo
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Neoplasias de Cabeça e Pescoço
- Neoplasias Glandulares e Epiteliais
- Doenças Esofágicas
- Carcinoma
- Neoplasias de Células Escamosas
- Carcinoma de Células Escamosas
- Neoplasias Esofágicas
- Carcinoma Espinocelular de Esôfago
Outros números de identificação do estudo
- NFEC-2024-242
Plano para dados de participantes individuais (IPD)
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