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

May 13, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: • Adebrelimab and nab-paclitaxel, carboplatin in Combination With 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete response (pCR)
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection rate
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 22, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2025-799-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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