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Die klinische Studie NCT05659251 für Ösophagus-Plattenepithelkarzinom, Neoadjuvante Therapie ist aktiv, nicht rekrutierend. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Serplulimab Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma Phase 2 48 Immuntherapie
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT05659251 untersucht Behandlung im Zusammenhang mit Ösophagus-Plattenepithelkarzinom, Neoadjuvante Therapie. Diese interventionsstudie der Phase 2 hat den Status aktiv, nicht rekrutierend und startete am 1. Dezember 2022. Es ist geplant, 48 Teilnehmer aufzunehmen. Durchgeführt von Second Affiliated Hospital, School of Medicine, Zhejiang University wird der Abschluss für 31. Dezember 2029 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 2. Dezember 2025 aktualisiert.
Kurzbeschreibung
China with high incidence of esophageal cancer, the number of new cases and deaths account for about 50% of the world every year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma patients was not significantly decreased. For patients with locally advanced esophageal cancer, direct surgery is not e...Mehr anzeigen
Offizieller Titel
A Prospective, Single-arm, Single-center, Exploratory Study of the Safety and Efficacy of Serplulimab Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma
Erkrankungen
Ösophagus-PlattenepithelkarzinomNeoadjuvante TherapiePublikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:Weitere Studien-IDs
- 2022-1022
NCT-Nummer
Studienbeginn (tatsächlich)
2022-12-01
Zuletzt aktualisiert
2025-12-02
Studienende (vorauss.)
2029-12-31
Geplante Rekrutierung
48
Studientyp
Interventionsstudie
PHASE
Phase 2
Status
Aktiv, nicht rekrutierend
Stichwörter
serplulimab
Esophageal Squamous Cell Carcinoma
Neoadjuvant Treatment
Esophageal Squamous Cell Carcinoma
Neoadjuvant Treatment
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellSerplulimab Preoperative neoadjuvant therapy for 3 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.
Serplulimab can be maintained 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. | Serplulimab, Albumin paclitaxel, carboplatin AUC=5, neoadjuvant therapy Serplulimab 4.5mg/kg, IV, Day 1; Albumin paclitaxel 260mg/m2, Day 1; carboplatin AUC=5, Day 1; Preoperative neoadjuvant therapy for 3 cycles, one cycle every 21 days. Ösophagektomie 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 Ivor-Lewis (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 t...Mehr anzeigen sample Blood, Tumour will be Collected from participant. Fate of sample is Destruction after use.
5 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. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Pathological Complete Response (PCR) | No residual invasive tumor cells were found in the pathological examination of resected specimens, including the primary tumor and lymph nodes. | 1 month after surgery |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
major pathological response (MPR) | In the pathological examination of resected specimens, the proportion of residual tumor cells was less than 10%. | 1 month after surgery |
Objective Response Rate (ORR) | The proportion of subjects with imaging PR or CR assessed according to RECIST 1.1 criteria | before 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 surgery | 2-year and 5-year after surgery |
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 | The pathological results will showed that the incision margin was negative and no residual cancer cells were found under the microscope | 1 month after 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 |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- 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 IIA-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 UniversityKeine Kontaktdaten vorhanden
1 Studienstandorte in 1 Ländern
China
2nd Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China, 310009, China