- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07595770
Adebrelimab Combined With Neoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ANCRE)
13. maj 2026 opdateret af: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
A Study on the Safety and Efficacy of Adalimumab Combined With Chemoradiotherapy as Neoadjuvant Therapy for Esophageal Squamous Cell Carcinoma
This study aims to systematically evaluate the safety and efficacy of adalimumab combined with paclitaxel, carboplatin, and short-course radiotherapy in the neoadjuvant treatment of esophageal squamous cell carcinoma.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
CROSS Study showed that the pathological complete response (pCR) rate of patients with esophageal cancer (23% of whom were esophageal squamous cell carcinoma, ESCC) after neoadjuvant radiotherapy and chemotherapy was 29%.
NEOCRTEC5010 Study showed that the pCR rate was 43.2% in locally advanced esophageal squamous cell carcinoma, which means that more than half of patients still cannot achieve ideal therapeutic effects from existing treatment options.
In addition, the recurrence rate after surgical resection compromises the long-term survival rate of patients.
Therefore, exploring new treatment strategies to improve the treatment efficacy and survival rate of esophageal cancer patients has important clinical significance.
Currently, the significance of immunotherapy combined with chemoradiotherapy in terms of pathological complete response (pCR) rates and postoperative survival quality for locally advanced esophageal squamous cell carcinoma remains unclear.
Therefore, this study aims to systematically evaluate the safety and efficacy of adebrelimab in combination with paclitaxel, carboplatin, and short-course radiotherapy as neoadjuvant therapy for ESCC.
By integrating immunotherapy with existing standard treatment regimens, this study seeks to significantly improve pCR rates, optimize surgical resection outcomes, ultimately prolong disease-free survival (DFS), and enhance overall survival (OS).
The implementation of this study is expected to provide innovative approaches and methods for the clinical treatment of ESCC, holding important clinical application value and significance.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
37
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Baisheng Chen, M.D, PhD
- Telefonnummer: +86-13560471611
- E-mail: Pason06213367@163.com
Studiesteder
-
-
Guangdong
-
Guangzhou, Guangdong, Kina
- Rekruttering
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
-
Kontakt:
- Baisheng Chen Chen
- Telefonnummer: +86-13560471611
- E-mail: Pason06213367@163.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- - 1. Provided informed consent and sign the informed consent form;
- 2. Male or female, Aged 18-75 years (counted on the date of signing informed consent);
- 3. Pathological confirmed ESCC;
- 4. Patients assessed by thoracic oncologists as resectable without distant metastasis
- 5. Patients evaluate with clinical staging of T1-4aN1-3M0 or T3-4aN0M0(AJCC 9.0) based on imaging and pathological examination results;
- 6. Have at least one assessable lesion according to the RECIST V1.1
- 7. ECOG-PS score: 0-1;
- 8. Patients with normal function of organs such as heart, brain, lungs, and kidneys who can tolerate surgery;
- 9. With a life expectancy of ≥ 6 weeks;
- 10. Adequate major organ function without severe hematologic, cardiac, pulmonary, hepatic, renal, or bone marrow dysfunction, and no immunodeficiency disease;
Exclusion Criteria:
- 1. Patients who have received or are currently receiving chemotherapy, radiotherapy, immunotherapy, or targeted therapy
- 2. Patients with distant metastasis or inability to undergo resection after evaluation by thoracic surgeons
- 3. Simultaneously developing tumors in other parts of the body
- 4. Severe impairment of heart, liver, and kidney function (heart function grade 3-4, ALT and/or AST exceeding the upper limit of normal by more than 1.5 times, Cr (serum creatinine) exceeding the upper limit of normal by more than 1.5 times)
- 5. Patients with a history of autoimmune diseases who were receiving immunosuppressive therapy prior to enrollment, with immunosuppressive doses>10 mg/day or oral prednisone for more than 2 weeks
- 6. Severe allergy to immune preparations
- 7. Abnormal coagulation function: (PT>16s, APTT>53s, TT>21s, Fib<1.5 g/L), bleeding tendency or during thrombolytic or anticoagulant therapy
- 8. Pregnancy or lactation period
- 9. Other situations as judged by investigators not suitable for inclusion.;
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Adebrelimab and nab-paclitaxel plus carboplatin followed by radiotherapy
Patients would receive Adebrelimab (IV 1200mg d1) and nab-paclitaxel (IV 220 mg/m²d1) plus carboplatin (AUC = 5, d1) for two 21-day cycles, followed by one week off for radiotherapy (2.5 ⨉12 Gy).
After radiotherapy, another cycle of Adebrelimab (IV 1200mg d1) would be given.
4 to 6 weeks after completing the neoadjuvant therapy, patients would undergo esophagectomy.
|
Patients would receive Adebrelimab (IV 1200mg d1) and nab-paclitaxel (IV 220 mg/m²d1) plus carboplatin (AUC = 5, d1) for two 21-day cycles, followed by one week off for radiotherapy (2.5 ⨉12 Gy).
After radiotherapy, another cycle of Adebrelimab (IV 1200mg d1) would be given.
4 to 6 weeks after completing the neoadjuvant therapy, patients would undergo esophagectomy.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pathological complete response (pCR)
Tidsramme: From patient enrollment to the end of surgery
|
The proportion of subjects with no residual viable tumor cells(ypT0N0) in the primary tumor and lymph nodes; that is, the proportion of patients who have achieved complete remission among PPS(Per-Protocol Set).
|
From patient enrollment to the end of surgery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
R0 resection rate
Tidsramme: From patient enrollment to the end of surgery
|
The proportion of patients with tumor margins showing no residual cancer cells under the microscope after surgical resection.
That is, the proportion of patients in PPS achieving R0 resection.
|
From patient enrollment to the end of surgery
|
|
Disease free survival (DFS)
Tidsramme: up to 24 months post-surgery
|
Disease free survival (DFS) refers to the time from the start of treatment until disease recurrence or death from any cause, whichever occurs first.
|
up to 24 months post-surgery
|
|
Overall survival (OS)
Tidsramme: up to 24 months after surgery
|
OS is the time interval from the start of treatment to death due to any reason or loss of follow-up
|
up to 24 months after surgery
|
|
Major pathological remission (MPR)
Tidsramme: From patient enrollment to the end of surgery
|
Major pathological remission (MPR) refers to the percentage of residual tumor cells in the tumor bed after neoadjuvant therapy being ≤ 10%, regardless of whether there are residual tumor cells in the lymph nodes.
|
From patient enrollment to the end of surgery
|
|
Progression free survival (PFS)
Tidsramme: Up to 24 months post-surgery
|
PFS is defined as the time from the start of treatment to the date of first documentation of disease progression, or date of death, whichever occurred first.
|
Up to 24 months post-surgery
|
|
Event free survival (EFS)
Tidsramme: From patient enrollment to the end of surgery
|
EFS refers to the time from the start of treatment to the occurrence of any event, including disease progression, cessation of treatment for any reason, or death.
|
From patient enrollment to the end of surgery
|
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Adverse Events
Tidsramme: from the first drug administration to within 30 days for the last Adebrelimab dose
|
Number of adverse events.
The evaluation criteria for adverse reactions are based on the American Cancer Institute Common Adverse Event Terminology 4.0 (CTCAE 5.0) and the Acute Radiation Injury Grading Standards of the American Oncology Radiotherapy Collaboration Group (RTOG).
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from the first drug administration to within 30 days for the last Adebrelimab dose
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
22. maj 2026
Primær færdiggørelse (Anslået)
1. januar 2028
Studieafslutning (Anslået)
1. oktober 2029
Datoer for studieregistrering
Først indsendt
13. maj 2026
Først indsendt, der opfyldte QC-kriterier
13. maj 2026
Først opslået (Faktiske)
19. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Neoplasmer efter histologisk type
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Neoplasmer i hoved og hals
- Neoplasmer, kirtel og epitel
- Esophageale sygdomme
- Karcinom
- Neoplasmer, pladecelle
- Karcinom, pladecelle
- Esophageale neoplasmer
- Esophageal pladecellekarcinom
- Organiske kemikalier
- Terapeutik
- Koordinationskomplekser
- Carboplatin
- Strålebehandling
- 130-nm albuminbundet paclitaxel
Andre undersøgelses-id-numre
- SYSKY-2025-799-02
Plan for individuelle deltagerdata (IPD)
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