Efficacy and Safety of Adebrelimab Combined With Chemoradiotherapy in Patients With Unresectable Locally Advanced or Postoperative Recurrent Esophageal Squamous Cell Carcinoma

April 13, 2026 updated by: Nanfang Hospital, Southern Medical University

A Phase II Clinical Study on the Efficacy and Safety of Adebrelimab Combined With Chemoradiotherapy in Patients With Unresectable Locally Advanced or Postoperative Recurrent Esophageal Squamous Cell Carcinoma

This study was a single-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 20 mg/kg 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

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
        • Nanfang Hospital, Southern Medical 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. Age 18-75 years old, gender unlimited
  2. Esophageal squamous cell carcinoma confirmed by histology and unresectable locally advanced or postoperative recurrence
  3. 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
  4. ECOG: 0~1
  5. 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:

  1. Other malignant tumors have been diagnosed within the previous 5 years
  2. There is distant organ metastasis (according to AJCC stage, supraclavicular lymph node metastasis is M1, which should be excluded)
  3. Lesions invading the trachea or large blood vessels, or investigators judge that there is a high risk of esophageal/tracheal fistula or bleeding
  4. Have any history of active autoimmune disease or autoimmune disease
  5. Have clinical symptoms or diseases of the heart that are not under control
  6. Active infection or fever (except definite tumor fever)
  7. History or evidence of interstitial lung disease or active non-infectious pneumonia
  8. Patients with immune dysfunction and active hepatitis
  9. Those who have previously received PD-1 or PD-L1 antibody therapy
  10. Allergic to any drug in this protocol
  11. Patients receiving immunosuppressive drugs or corticosteroids >10mg/ day of prednisone therapeutic dose within 14 days prior to enrollment
  12. Patients who had received radiotherapy, chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to enrollment
  13. Pregnant or lactating women

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 combined with chemoradiotherapy
Drug: Adebrelimab: 20mg/kg day1, Q3W, 3 times
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: 20mg/kg day1, Q3W, 3 times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate at 3 months after radiotherapy (ORR)
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From the date of treatment initiation (or diagnosis) to the date of death from any cause, assessed up to 120 months
From the date of treatment initiation (or diagnosis) to the date of death from any cause, assessed up to 120 months
Progression free survival
Time Frame: The time from the start of treatment to tumor progression or death due to any cause， assessed up to 120 months
The time from the start of treatment to tumor progression or death due to any cause， assessed up to 120 months
Clinical complete response rate
Time Frame: "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
Time Frame: "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

Collaborators and Investigators

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

Sponsor

Nanfang Hospital, Southern Medical University

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 (Actual)

June 6, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

March 2, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2024-242

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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