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Adebrelimab Combined With Neoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ANCRE)

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

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

Studiesteder

    • Guangdong
      • Guangzhou, Guangdong, Kina
        • Rekruttering
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
        • Kontakt:

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
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).
from the first drug administration to within 30 days for the last Adebrelimab dose

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

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

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