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Adbelimumab Combined With Chemotherapy and Apatinib in Patients With Resectable Esophageal Squamous Cell Carcinoma Fase II 35 Imunoterapia Terapia alvo Sobrevida global
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O estudo clínico NCT06576973 procura avaliar tratamento para Carcinoma de Células Escamosas do Esôfago, Tratamento neoadjuvante. Este é um estudo intervencionista de Fase II. Seu status atual é: em recrutamento. O estudo começou em 8 de agosto de 2024 e pretende incluir 35 participantes. Coordenado por Second Affiliated Hospital, School of Medicine, Zhejiang University e deve ser concluído em 1 de dezembro de 2031. Essas informações foram atualizadas no ClinicalTrials.gov em 2 de dezembro de 2025.
Resumo
Esophageal cancer is a prevalent digestive tract tumor, with around 400,000 new cases and 300,000 deaths globally each year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma (ESCC) patients was not significantly decreased. For patients with locally advanced esophageal cancer, direct surgery is not...Mostrar mais
Título oficial
A Prospective, Single-arm, Single-center, Exploratory Study of the Safety and Efficacy of Adbelimumab Combined With Chemotherapy and Apatinib in Patients With Resectable Esophageal Squamous Cell Carcinoma
Condições médicas
Carcinoma de Células Escamosas do EsôfagoTratamento neoadjuvanteOutros IDs do estudo
- 2024-0949
Número NCT
Data de início (real)
2024-08-08
Última atualização postada
2025-12-02
Data de conclusão (estimada)
2031-12
Inscrição (estimada)
35
Tipo de estudo
Intervencionista
FASE
Fase II
Status
Em recrutamento
Palavras-chave
Adbelimumab
Chemotherapy
Apatinib
Esophageal Squamous Cell Carcinoma
Neoadjuvant Treatment
Chemotherapy
Apatinib
Esophageal Squamous Cell Carcinoma
Neoadjuvant Treatment
Propósito principal
Tratamento
Alocação do design
N/A
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalAdbelimumab, chemotherapy and apatinib Preoperative neoadjuvant therapy for 4 cycles. Radical surgery is performed 4-6 weeks after the last dose. Postoperative radiotherapy is determined according to the clinical situation and pathological stage of the patient. Adbelimumab can be aintained for a maximum of 1 year. During the study, patients were be followed until disease progression, withdrawal of informed consent, loss of follow-up, or death. | Adbelimumab, Albumin paclitaxel, Carboplatin, Apatinib Adbelimumab 1200mg Day 1; Albumin paclitaxel 260mg/m2, Day 1; carboplatin AUC=5, Day 1; Apatinib 250mg Po Day 2-4. Preoperative neoadjuvant therapy for 4 cycles, one cycle every 21 days. Esofagectomia Prior to each surgical procedure, the department engaged in comprehensive discussions and deliberations to ascertain and establish the most suitable course of action. Minimally invasive IvorLewis (intrathoracic anastomosis) or McKeown (neck anastomosis) esophagectomy, including two field extensive lymphadenectomies, was performed according to the tumor location. The resection length should be at least 5cm from the tu...Mostrar mais Collecting samples from participant Blood, Tumour will be Collected from participant. Fate of sample is Destruction after use. 20 ml of peripheral blood was collected the day before each of the immunotherapy sessions and after surgery. Tumour sample will be collected before neoadjuvant therapy and after surgery. |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Pathological Complete Response (PCR) | The pCR will be defined as the proportion of participants with absence of residual tumor in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant treatment. | 1 month after surgery |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Major Pathological Response (MPR) | The MPR will be defined as the proportion of participants with less 10% of residual tumor in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant treatment. | 1 month after surgery |
Objective Response Rate (ORR) | The ORR will be defined as the proportion of participants who have a complete response or partial response before surgery as assessed by the investigator per RECIST v1.1 in all participants with measurable disease at baseline | before surgery |
The changes in the peripheral blood immunoprofile and tumor tissue sample among non-PCR (NPCR) and PCR patients | By using mass spectrometry (CyTOF) and single-cell analysis, we comprehensively characterized the immune landscape in the peripheral blood and tumor sample of ESCC patients before and after anti-PD-1 immunotherapy, aiming to explore the immune subsets correlated with neoadjuvant immunotherapy response. | 3 months after surgery |
2-year and 5-year overall survival | The proportion of all study cases in which no death from any cause occurred within 2 years and 5 years after enrolled | 2-year and 5-year after enrolled |
Incidence of Treatment-related Adverse Events | Incidence of Treatment-related Adverse Events as Assessed by CTCAE v5.0 | 1 month after surgery |
R0 resection rate | This will be defined as the proportion of participants with R0 resection | 1 month after surgery |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
- Signed informed consent.
- Patients age 18 to 75 years old.
- Primary resectable, histologically confirmed esophageal squamous cell cancer.
- Esophageal squamous cell carcinoma the clinical stage was II-IVA (according to AJCC TNM stage, 8th edition).
- ECOG PS 0-1.
- No distant metastasis, the diseases could be resectable assessed by thoracic oncologist.
- With significant cardiovascular disease.
- Current treatment with anti-viral therapy or HBV.
- Female patients who are pregnant or lactating.
- History of malignancy within 5 years prior to screening.
- Active or history of autoimmune disease or immune deficiency.
- Signs of distant metastases.
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityContato central do estudo
Contato: Ming Wu, M.D, +8613757118715, [email protected]
1 Locais do estudo em 1 países
China
2nd Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China, 310009, China
Ming Wu, M.D, Contato, +8613757118715, [email protected]
Em recrutamento