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Radiotherapy With GX Regimen as Adjuvant Therapy for High-risk Patients Following Pancreatic Cancer Surgery

A Prospective, Multicenter, Randomized Controlled Phase III Study on Radiotherapy Combined With GX Regimen as Adjuvant Therapy for High-risk Patients Following Pancreatic Cancer Surgery

Pancreatic cancer is a highly fatal malignant tumor. Simple surgical operations can no longer meet the treatment needs of pancreatic cancer patients. Postoperative adjuvant chemotherapy has a significant effect, which can effectively prevent or delay tumor recurrence and prolong the overall survival period of pancreatic cancer patients. Based on this, many guidelines both at home and abroad actively recommend that pancreatic cancer patients receive adjuvant chemotherapy after surgery (if there are no contraindications). Radiotherapy is one of the most commonly used local treatment methods. It can be used as a neoadjuvant or adjuvant therapy to increase the tumor resection rate or reduce the recurrence rate, or as a treatment approach for locally unresectable pancreatic cancer to improve local control. After complete gross resection of pancreatic cancer, the role of radioadjuvant therapy has always been controversial, and its indications for use remain unclear. However, recent clinical studies using modern radiotherapy equipment and techniques have shown that an increasing amount of data indicates that radiotherapy can benefit in the treatment of neoadjuvant, adjuvant and locally advanced pancreatic cancer. Evidence supporting adjuvant radiotherapy after pancreatectomy remains scarce. Therefore, whether screening high-risk factor populations for adjuvant radiotherapy may improve the prognosis of pancreatic cancer is an important research.

Visão geral do estudo

Status

Recrutamento

Condições

Tipo de estudo

Intervencional

Inscrição (Estimado)

288

Estágio

  • Fase 3

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: Maobin Meng
  • Número de telefone: 022-23340123-1111
  • E-mail: mmeng@tmu.edu.cn

Locais de estudo

    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Recrutamento
        • Tianjin medical university hospital and institute
        • Investigador principal:
          • Jihui Hao
        • Contato:
        • Subinvestigador:
          • Maobin Meng

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

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Understand and voluntarily participate in this study and sign the informed consent form
  • Age ≥18 years old and ≤75 years old, male and female.
  • Confirmed as pancreatic ductal adenocarcinoma by histopathology or cytology, with no evidence of distant metastasis confirmed by imaging.
  • The preoperative neoadjuvant chemotherapy regimen is not limited and should not exceed 4 cycles. After the operation was completed, at least one postoperative high-risk factor was present :R1/R2 resection. Regional LN transfer Neurovascular invasion The pathology is poorly differentiated. Tumor height >4cm;
  • No disease progression was evaluated by CT or MRI after the operation.
  • The subjects have sufficient organ and bone marrow functions: absolute neutrophil count ≥1.5×109, platelet count ≥80×109, hemoglobin ≥90g/L; Total bilirubin levels ≤1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 times ULN. Serum creatinine ≤1.5 times ULN or creatinine clearance ≥60 ml/min(Cockcroft-Gault formula);
  • ECOG PS score 0-1;
  • The expected postoperative survival period is ≥3 months;
  • Women of childbearing age who are not pregnant and have no pregnancy plans. Patients of childbearing age and their spouses are willing to take contraceptive measures that have been medically approved.

Exclusion Criteria:

  • Had received radiotherapy, palliative chemotherapy or other targeted or immunotherapy for anti-tumor treatment before pancreatic tumor resection;
  • Suffering from severe underlying diseases, including but not limited to: active infections that require systemic medication treatment; Uncontrolled diabetes and hypertension; Negligent compensatory heart failure (NYHA grades III and IV), unstable angina, and acute myocardial infarction occurred within 3 months before enrollment. Malignant peritoneal effusion or pleural effusion; Severe portal hypertension or imaging manifestations of cavernous changes in the portal vein; Gastric outlet obstruction, respiratory insufficiency (requiring oxygen inhalation) and severe lung diseases; Central nervous system diseases, mental disorders;
  • There is a history of other malignant tumors (cured basal cell carcinoma of the skin and cervical carcinoma in situ)
  • There is bleeding or coagulation disorder;
  • Postoperative complications such as bleeding, pancreatic fistula, gastric emptying disorder, abdominal infection, and biliary fistula occur, which prevent the patient from receiving adjuvant treatment within 12 weeks after the operation.
  • Those who are allergic to the drugs or their components used in this plan;
  • Known to be infected with HIV or syphilis, or currently in the active stage of hepatitis (hepatitis B, hepatitis C);
  • Female subjects who are pregnant or breastfeeding, or plan to become pregnant during the study period, or female spouses of male subjects;
  • The subjects had poor compliance and were unable to follow the various procedures, restrictions or requirements of the study, etc.
  • There are other reasons that the researcher deems unsuitable for participation in this study.

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: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Radiotherapy plus GX group
After 3 cycles of GX chemotherapy, capecitabine is taken orally simultaneously with radiotherapy. After concurrent chemoradiotherapy, continue with GX chemotherapy.
After 3 cycles of GX chemotherapy, capecitabine is taken orally simultaneously with radiotherapy. After concurrent chemoradiotherapy, continue with GX chemotherapy. Radiotherapy target and dose: Tumor bed, anastomosis, adjacent lymphatic drainage area :50 Gy; R1 resection area: 60 Gy; R2 resection area: 66-70 Gy (silver clip position), once daily.
Comparador Ativo: GX group
Gemcitabine and Capecitabine, repeated every 21 days as one cycle. Administration for 6 cycles.
Gemcitabine (G): Intravenous infusion of 1000 mg/m2 for more than 30 minutes, administered on day 1 and day 8, repeated every 21 days. Capecitabine (X): 1660-2000mg/m2 per day, taken orally in two divided doses, from day 1 to day 14, repeated every 21 days as one cycle. Administration for 6 cycles, every 3 weeks .

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
DFS
Prazo: From date of randomization until the first tumor recurrence, metastasis or death of the subject for any reason (whichever occurs first) assessed up to 24 months
Defined as the time from random assignment to the first tumor recurrence, metastasis or death of the subject for any reason (whichever occurs first)
From date of randomization until the first tumor recurrence, metastasis or death of the subject for any reason (whichever occurs first) assessed up to 24 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
OS
Prazo: From date of randomization until death from any cause or last follow-up, assessed up to 24 months
The time from random assignment to death due to any cause.
From date of randomization until death from any cause or last follow-up, assessed up to 24 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

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 (Estimado)

22 de maio de 2026

Conclusão Primária (Estimado)

1 de maio de 2029

Conclusão do estudo (Estimado)

1 de maio de 2031

Datas de inscrição no estudo

Enviado pela primeira vez

21 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de junho de 2026

Primeira postagem (Real)

8 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

8 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de junho de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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

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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