Efficacia e sicurezza di adebrelimb combinato con la chemioradioterapia in pazienti con carcinoma esofageo a cellule esofagei ricorrenti localmente avanzate o postoperatorie esofagee
Uno studio clinico di fase II sull'efficacia e sulla sicurezza di adebrelimab combinato con la chemioradioterapia in pazienti con carcinoma squamoso esofageo non resettabile
This study was a multi-center, single-arm, open-label phase II clinical trial. Thirty patients with unresectable locally advanced or postoperative recurrent esophageal squamous cell carcinoma were treated with concurrent chemoradiotherapy combined with immunotherapy. The radiotherapy regimen was intensity-modulated radiotherapy with PGTV at 50-50.4 Gy/25-28 fractions, 1.8-2 Gy per fraction, five times a week. The chemotherapy regimen was paclitaxel 50 mg/m2 and cisplatin 25 mg/m2 intravenous infusion on day 1, once a week for five times. The immunotherapy was with adebutilimab at 1200 mg on day 1, every three weeks for three times. One week before radiotherapy, gastroscopy, chest CT or PET-CT images were taken as the baseline standard. Based on the results of gastroscopy, chest CT or PET-CT before and after treatment, the number of patients with complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) in the two groups was observed. The objective response rate (ORR) was calculated as CR + PR, and the disease control rate (DCR) was calculated as CR + PR + SD. The progression-free survival (PFS), overall survival (OS), 1-year and 2-year survival rates and adverse reactions were also statistically analyzed.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
-
Guangdong
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Guangzhou, Guangdong, Cina
- Nanfang Hospital, Southern Medical University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age 18-75 years old, gender unlimited
- Esophageal squamous cell carcinoma confirmed by histology and unresectable locally advanced or postoperative recurrence
- According to the solid tumor efficacy evaluation criteria (RECIST1.1), there is at least one measurable lesion; And the lesion had not received prior radiotherapy
- ECOG: 0~1
- Expected survival ≥12 weeks 6. Laboratory examination: neutrophils ≥1.5 x 109/L, platelets ≥100 x 109/L; Hemoglobin ≥ 9g/L; Albumin ≥ 2.8g/dL; Bilirubin ≤1.5 times ULN, ALT and AST≤2.5 times ULN
7: Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up 8: Tissue samples should be provided for biomarker analysis such as (PD-L1). Newly acquired tissues are preferred, and 15 5-6um thick paraffin sections can not be provided for archiving by the recent organizer
Exclusion Criteria:
- Other malignant tumors have been diagnosed within the previous 5 years
- There is distant organ metastasis (according to AJCC stage, supraclavicular lymph node metastasis is M1, which should be excluded)
- Lesions invading the trachea or large blood vessels, or investigators judge that there is a high risk of esophageal/tracheal fistula or bleeding
- Have any history of active autoimmune disease or autoimmune disease
- Have clinical symptoms or diseases of the heart that are not under control
- Active infection or fever (except definite tumor fever)
- History or evidence of interstitial lung disease or active non-infectious pneumonia
- Patients with immune dysfunction and active hepatitis
- Those who have previously received PD-1 or PD-L1 antibody therapy
- Allergic to any drug in this protocol
- Patients receiving immunosuppressive drugs or corticosteroids >10mg/ day of prednisone therapeutic dose within 14 days prior to enrollment
- Patients who had received radiotherapy, chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to enrollment
- Pregnant or lactating women
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Adebrelimb combinato con chemioradioterapia
|
Concurrent Chemoradiotherapy combined with Immunotherapy，including： Radiotherapy: intensity modulated radiotherapy, PGTV 50-50.4Gy/25-28F, 1.8-2Gy/F, 5 times a week; Chemotherapy: paclitaxel 50mg/ m2 + cisplatin 25mg/ m2, intravenous infusion of day1, once a week, a total of 5 times; Adebrelimab: 1200 mg day1, Q3W, 3 times. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Objective response rate at 3 months after radiotherapy (ORR)
Lasso di tempo: Three months after radiation
|
ORR includes Complete Response (CR) and Partial Response (PR) according to accepted response evaluation criteria (such as solid tumor RECIST version 1.1), (1) Complete response (CR) : Except for nodular disease, all target lesions disappeared completely. All target nodules must be reduced to normal size (short axis < 10 mm). All target lesions must be evaluated. (2) Partial response (PR) : Total diameter of all measurable target lesions is ≥ 30% below baseline. The short diameter was used for the sum of the target nodules, while the longest diameter was used for the sum of all other target lesions. All target lesions must be evaluated. |
Three months after radiation
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Sopravvivenza globale
Lasso di tempo: Dalla data di inizio del trattamento (o diagnosi) alla data di morte da qualsiasi causa, valutata fino a 120 mesi
|
Dalla data di inizio del trattamento (o diagnosi) alla data di morte da qualsiasi causa, valutata fino a 120 mesi
|
|
|
Sopravvivenza libera da progressione
Lasso di tempo: Il tempo dall'inizio del trattamento alla progressione del tumore o alla morte dovuta a qualsiasi causa ， valutata fino a 120 mesi
|
Il tempo dall'inizio del trattamento alla progressione del tumore o alla morte dovuta a qualsiasi causa ， valutata fino a 120 mesi
|
|
|
Clinical complete response rate
Lasso di tempo: "Monitored throughout the treatment period and during follow-up, an average of 2 years"
|
Except for nodular disease, all target lesions disappeared completely. All target nodules must be reduced to normal size (short axis < 10 mm). All target lesions must be evaluated |
"Monitored throughout the treatment period and during follow-up, an average of 2 years"
|
|
Quality of life scores of cancer patients
Lasso di tempo: "Monitored throughout the treatment period and during follow-up, an average of 2 years
|
Assess the patient's physical function, psychological state, social function, symptom burden, and overall health status through telephone follow-ups, return visits for review, and other methods .The measurement tool is SF-36 Quality of Life Assessment Scale |
"Monitored throughout the treatment period and during follow-up, an average of 2 years
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Neoplasie per sede
- Neoplasie
- Neoplasie per tipo istologico
- Neoplasie gastrointestinali
- Neoplasie dell'apparato digerente
- Malattie dell'apparato digerente
- Malattie gastrointestinali
- Neoplasie della testa e del collo
- Neoplasie, ghiandolari ed epiteliali
- Malattie esofagee
- Carcinoma
- Neoplasie, cellule squamose
- Carcinoma, cellule squamose
- Neoplasie esofagee
- Carcinoma a cellule squamose dell'esofago
Altri numeri di identificazione dello studio
- NFEC-2024-242
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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