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Adbelimumab Combined With Chemotherapy and Apatinib in Patients With Resectable Esophageal Squamous Cell Carcinoma Phase II 35 Immunothérapie Thérapie ciblée Survie globale

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT06576973 est conçu pour étudier le traitement de Carcinome épidermoïde de l'œsophage, Traitement néoadjuvant. Il s'agit d'une étude interventionnel en Phase II. Son statut actuel est : en recrutement. L'étude a débuté le 8 août 2024 et vise à recruter 35 participants. Dirigée par Second Affiliated Hospital, School of Medicine, Zhejiang University, l'étude devrait être terminée d'ici le 1 décembre 2031. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 2 décembre 2025.
Résumé succinct
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...Afficher plus
Titre officiel

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

Pathologies
Carcinome épidermoïde de l'œsophageTraitement néoadjuvant
Autres identifiants de l'étude
  • 2024-0949
Numéro NCT
NCT06576973
Date de début (réel)
2024-08-08
Dernière mise à jour publiée
2025-12-02
Date de fin (estimée)
2031-12
Inscription (estimée)
35
Type d'étude
Interventionnel
PHASE
Phase II
Statut
En recrutement
Mots clés
Adbelimumab
Chemotherapy
Apatinib
Esophageal Squamous Cell Carcinoma
Neoadjuvant Treatment
Objectif principal
Traitement
Méthode d'allocation
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalAdbelimumab, 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.
Œsophagectomie
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...Afficher plus
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.
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
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
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
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
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  1. Signed informed consent.
  2. Patients age 18 to 75 years old.
  3. Primary resectable, histologically confirmed esophageal squamous cell cancer.
  4. Esophageal squamous cell carcinoma the clinical stage was II-IVA (according to AJCC TNM stage, 8th edition).
  5. ECOG PS 0-1.
  6. No distant metastasis, the diseases could be resectable assessed by thoracic oncologist.

  1. With significant cardiovascular disease.
  2. Current treatment with anti-viral therapy or HBV.
  3. Female patients who are pregnant or lactating.
  4. History of malignancy within 5 years prior to screening.
  5. Active or history of autoimmune disease or immune deficiency.
  6. Signs of distant metastases.
Second Affiliated Hospital, School of Medicine, Zhejiang University logoSecond Affiliated Hospital, School of Medicine, Zhejiang University
Contact central de l'étude
Contact: Ming Wu, M.D, +8613757118715, [email protected]
1 Centres de l'étude dans 1 pays

China

2nd Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China, 310009, China
Ming Wu, M.D, Contact, +8613757118715, [email protected]
En recrutement