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- Ensaio Clínico NCT07808853
Node-Sparing Short-Course Radiotherapy (25 Gy/5 Fractions) Combined With Chemoimmunotherapy as Neoadjuvant Treatment for Locally Advanced Esophageal Squamous Cell Carcinoma:A Prospective Single-Arm, Phase II Study (NeoSCRTIC-01)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The study is designed as a Simon optimal two-stage, single-arm phase II trial. The target sample size is 33 participants, allowing for approximately 10% attrition. In stage 1, 15 participants will be enrolled; if at least 4 achieve pathologic complete response, enrollment will proceed to stage 2. A further 15 evaluable participants will then be enrolled. The protocol considers the regimen promising if at least 15 of 30 evaluable participants achieve pathologic complete response.
Eligible participants are treatment-naive adults aged 18-75 years with PET-CT and pathologically confirmed thoracic esophageal squamous cell carcinoma, clinical stage cT1b-3N1-2M0 or cT2-3N0M0 (AJCC 9th edition), ECOG performance status 0-1, measurable disease by RECIST v1.1, and disease considered amenable to R0 resection.
Neoadjuvant treatment consists of camrelizumab 200 mg intravenously on Day 1 every 3 weeks plus nab-paclitaxel 260 mg/m² on Day 1 and carboplatin AUC 5 on Day 1 for three cycles. Short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle, targeting only the primary tumor and positive lymph nodes and sparing elective lymphatic drainage regions. Tumor imaging is performed after the second cycle and before surgery. McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant therapy when hematologic and organ function have recovered. Postoperative survival follow-up is planned every 3 months for 3 years.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
Contactos e Locais
Contato de estudo
- Nome: Hongying Liao MD, Professor / Chief Physician, MD and PhD
- Número de telefone: +86-020-35919121
- E-mail: liaohy2@mail.sysu.edu.cn
Locais de estudo
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Guangdong
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Guanzhou, Guangdong, China, 510655
- Recrutamento
- The Sixth Affiliated Hospital, Sun Yat-sen University
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Contato:
- Hongying Liao MD, Professor / Chief Physician, MD and PhD
- Número de telefone: +86-020-35919121
- E-mail: liaohy2@mail.sysu.edu.cn
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Contato:
- Jiayan Wu MD, MD and PhD
- Número de telefone: +86-020-35919121
- E-mail: wujy526@mail.sysu.edu.cn
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Investigador principal:
- Hongying Liao, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Written informed consent before enrollment.
- Age 18 to 75 years, any sex.
- Treatment-naive esophageal squamous cell carcinoma confirmed by pathology and PET-CT.
- Clinical stage cT1b-3N1-2M0 or cT2-3N0M0 (stage II/III according to the AJCC 9th edition).
- Disease assessed as amenable to R0 surgical resection before treatment.
- At least one measurable lesion according to RECIST v1.1.
- ECOG performance status 0-1.
- Adequate organ function: absolute neutrophil count ≥1,500/mm³; platelets ≥100,000/mm³; hemoglobin ≥9 g/dL; serum creatinine ≤1.5 mg/dL and/or creatinine clearance ≥60 mL/min; bilirubin ≤1.5×ULN; AST and ALT ≤1.5×ULN; no blood components or hematopoietic growth factors within 14 days.
- For women of childbearing potential: medically accepted contraception during treatment and for 3 months afterward; negative serum or urine HCG within 7 days before enrollment; not breastfeeding.
- For men who are not surgically sterile: agreement to use medically accepted contraception with their partner during treatment and for 3 months afterward.
- Willingness to participate and comply with safety and survival follow-up.
Exclusion Criteria:
- Prior radiotherapy, chemotherapy, prolonged/high-dose corticosteroid therapy, surgery, or molecular targeted therapy.
- Previous or concurrent other malignancy.
- Prior PD-1/PD-L1 therapy; known allergy to macromolecular protein preparations or any component of PD-1 therapy.
- Active autoimmune disease or relevant autoimmune disease history as specified in the protocol.
- Immunosuppressive agents for immunosuppression within 2 weeks before enrollment.
- Symptomatic pleural or peritoneal effusion requiring therapeutic puncture or drainage.
- Poorly controlled clinically significant cardiac disease as specified in the protocol.
- Abnormal coagulation with bleeding tendency or thrombolytic/anticoagulant therapy.
- Recent gastrointestinal conditions associated with bleeding or perforation risk.
- Severe bleeding within 3 months, hemoptysis within 4 weeks, or thromboembolic event within 12 months according to protocol thresholds.
- Active infection or unexplained fever >38.5°C during screening or before first dose.
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks before study treatment.
- History/current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severe pulmonary dysfunction.
- Congenital/acquired immunodeficiency including HIV infection, or active hepatitis outside protocol-defined limits.
- Participation in another clinical study or completion of a previous clinical study within 1 month; anticipated need for other systemic anticancer therapy.
- Live vaccine within 4 weeks before study treatment or anticipated during the study.
- Known history of psychotropic drug abuse, alcohol abuse, or illicit drug abuse.
- Unable or unwilling to bear self-paid portions of study-related examinations or treatment.
- Any other condition considered by the investigator to compromise participant safety, study completion, or data/sample collection.
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 |
|---|---|
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Experimental: Neoadjuvant SCRT + Camrelizumab + Nab-Paclitaxel/Carboplatin
Participants receive three 3-week cycles of camrelizumab plus nab-paclitaxel and carboplatin.
Lymphatic-drainage-sparing short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle.
McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant treatment.
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Participants receive three 3-week cycles of camrelizumab plus nab-paclitaxel and carboplatin. Lymphatic-drainage-sparing short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle. McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant treatment. Drug: Camrelizumab Camrelizumab 200 mg intravenously on Day 1 of each 3-week cycle for 3 cycles. Drug: Nab-paclitaxel Nab-paclitaxel 260 mg/m² intravenously on Day 1 of each 3-week cycle for 3 cycles. Drug: Carboplatin Carboplatin AUC 5 intravenously on Day 1 of each 3-week cycle for 3 cycles. Radiation: Short-course radiotherapy 25 Gy in 5 fractions over 5 days, delivered to the primary tumor and radiographically positive lymph nodes while elective lymphatic drainage regions are spared. Procedure: McKeown esophagectomy McKeown esophagectomy with thoracoabdominal two-field lymph node dissection, planned 4-6 weeks after completion of neoadjuvant therapy (maximum extension of 2 additional |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pathologic Complete Response (pCR) Rate
Prazo: At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.
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Percentage of participants undergoing definitive surgery who have no residual viable tumor in the resected primary tumor and regional lymph nodes, defined in the protocol as ypT0N0.
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At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Major Pathologic Response (MPR) Rate
Prazo: At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.
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Major pathologic response (MPR) is defined as ≤10% residual viable tumor cells in the primary esophageal tumor resection specimen, regardless of lymph node status, as pre-specified in study protocol.
The percentage of participants achieving this protocol-defined MPR criterion in post-neoadjuvant surgical resection specimen will be calculated.
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At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.
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Objective Response Rate (ORR)
Prazo: From baseline to the preoperative tumor assessment, approximately 9-15 weeks after initiation of neoadjuvant therapy.
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Percentage of participants with complete response or partial response according to RECIST v1.1 based on protocol-specified imaging assessments.
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From baseline to the preoperative tumor assessment, approximately 9-15 weeks after initiation of neoadjuvant therapy.
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R0 Resection Rate
Prazo: Upon completion of final postoperative pathological assessment, expected within 7 days post-operatively
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Percentage of participants undergoing esophagectomy with microscopically negative resection margins.
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Upon completion of final postoperative pathological assessment, expected within 7 days post-operatively
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Disease-Free Survival (DFS) Rate
Prazo: 1 year and 3 years after surgery.
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Disease-free survival rate at 1 and 3 years.
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1 year and 3 years after surgery.
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Overall Survival (OS) Rate
Prazo: 1 year and 3 years after surgery.
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Overall survival rate at the specified time points.
Survival will be estimated using the Kaplan-Meier method.
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1 year and 3 years after surgery.
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.
- Pennathur A, Gibson MK, Jobe BA, Luketich JD. Oesophageal carcinoma. Lancet. 2013 Feb 2;381(9864):400-12. doi: 10.1016/S0140-6736(12)60643-6.
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026ZSLYEC-647
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