Clinical Study of Adbelimumab in the Adjuvant Treatment of Esophageal Squamous Cell Carcinoma.

NCT07266480 | Recruiting Phase 2

• 1 other identifier: ARL-ESCC
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluating the efficacy and safety of adebrelizumab for the adjuvant treatment of esophageal squamous cell cancer.

Conditions

Squamous Oesophageal Cancer

Outcome Measures

Primary Outcomes (1)

• DFS

  DFS is defined as the time from registration to the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause. Patients without an event are censored at the date of last evaluation.

  3 years

Secondary Outcomes (3)

• OS

  3 years

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  3 years

• Patient reported outcome (Quality of Life questionnaire of cancer patients)

  At the end of Cycle 1 (each cycle is 21 days)

Study Arms (2)

Adebrelizumab

EXPERIMENTAL

Adebrelizumab: 1200mg, iv, d1, q3w, 17 cycles

Drug: Adebrelizumab

close follow-up

NO INTERVENTION

Interventions

Adebrelizumab DRUG

Patients undergoing radical surgery to achieve R0 resection were randomised in a 1:1 ratio at 4-16 weeks postoperatively, with patients in the trial group receiving adjuvant treatment with adebrelizumab (up to 17 cycles)

Adebrelizumab

Eligibility Criteria

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

You may qualify if:

• Age:≥18 years old, male or female; 2.Histopathologically confirmed esophageal squamous cell cancer with initial clinical stage cT1b-2N1-3M0 or cT3-4aN0-3M0 in the thoracic esophagus; 3.Radical surgery with R0 resection 4-16 weeks prior to randomisation; 4.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 5.Expected survival ≥ 12 months; 6.Left ventricular ejection fraction is \>50%; 7.Normal functioning of major organs, i.e. meeting the following criteria:
• routine blood tests:
• HB≥90g/L；
• ANC≥1.5×109/L；
• PLT≥100×109/L；
• biochemical examination:
• ALT and AST\<2.5ULN（liver metastasis: ALT and AST\<5ULN）；
• TBIL≤1.5ULN；
• creatinine ≤1.5ULN； 8.Participants were willing to join in this study, written informed consent, good adherence and co-operation with follow up.

You may not qualify if:

• Patients initially diagnosed as unresectable (e.g. large metastatic lymph nodes) and treated with conversion therapy;
• Patients with severe postoperative complications who are not suitable for adjuvant therapy;
• Patients who have received any form of adjuvant therapy after surgery;
• Patients who have received or are receiving other chemotherapy, radiotherapy or targeted therapy;
• Pre-existing other malignancies, unless complete remission was achieved at least 5 years prior to enrolment and no other treatment is expected to be required during the study period;
• People with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;
• Pregnant or breastfeeding women and women of childbearing age with a history of immunodeficiency, including HIV-positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation who are not using contraception during the trial period;
• Presence of clinically uncontrolled cardiac symptoms or disease, including but not limited to, such as (1) NYHA class II or higher heart failure, (2) unstable angina, (3) myocardial infarction within 6 months, (4) clinically significant supraventricular or ventricular arrhythmia not clinically intervened with or poorly controlled after clinical intervention;
• Not suitable for enrolment in the investigator's comprehensive assessment.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

12, Jiankang road, Chang'an District, Shijiazhuang, Hebei 050000, China

Shijiazhuang, Hebei, China

RECRUITING

Central Study Contacts

Ziqiang Tian

CONTACT

18531118000; tizq12@vip.163.com

Study Design

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

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: December 5, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2030
• Last Updated: December 5, 2025

Record last verified: 2025-08

Locations

CN (1)