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

NCT06885814 | Recruiting Phase 2

• 1 other identifier: NFEC-2024-242
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Unresectable; locally advanced; postoperative recurrent; esophageal squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate at 3 months after radiotherapy (ORR)

  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 Outcomes (4)

• Overall survival

  From the date of treatment initiation (or diagnosis) to the date of death from any cause, assessed up to 120 months

• Progression free survival

  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

  "Monitored throughout the treatment period and during follow-up, an average of 2 years"

• Quality of life scores of cancer patients

  "Monitored throughout the treatment period and during follow-up, an average of 2 years

Study Arms (1)

Adebrelimab combined with chemoradiotherapy

EXPERIMENTAL

Drug: Adebrelimab: 20mg/kg day1, Q3W, 3 times

Interventions

Adebrelimab: 20mg/kg day1, Q3W, 3 times DRUG

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.

Adebrelimab combined with chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• : 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Wei Wang

CONTACT

86+18520529179; 29262574@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 20, 2025
• Study Start: June 6, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)