Squamous Oesophageal CancerPhase 2NCT07266480
Clinical Study of Adbelimumab in the Adjuvant Treatment of Esophageal Squamous Cell Carcinoma.
A Phase 2 study testing Adebrelizumab in people with Squamous Oesophageal Cancer, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
Evaluating the efficacy and safety of adebrelizumab for the adjuvant treatment of esophageal squamous cell cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Oesophageal Cancer
- What is being tested?
- Adebrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Sep 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.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:
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- 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.
Who cannot join
- 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;
- Patients with active, known or suspected autoimmune disease, including but not limited to: interstitial pneumonitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered for inclusion after hormone replacement therapy); patients with psoriasis or childhood asthma/allergies that have been in complete remission and do not require any intervention in adulthood may be considered for inclusion, but medical intervention with bronchodilator is required patients may not be included;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
12, Jiankang road, Chang'an District, Shijiazhuang, Hebei 050000, China
Shijiazhuang, Hebei
Ziqiang Tian
About this study
Official title: A Randomised, Controlled Clinical Study of Adebrelizumab for the Adjuvant Treatment of Esophageal Squamous Cell Cancer.
Evaluating the efficacy and safety of adebrelizumab for the adjuvant treatment of esophageal squamous cell cancer.
- Conditions
- Squamous Oesophageal Cancer
- Being tested
- Adebrelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelizumabDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Adebrelizumab | Experimental | Adebrelizumab: 1200mg, iv, d1, q3w, 17 cycles Receives: Drug: Adebrelizumab |
| close follow-up | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (3)
OS
Baseline to measured date of death from any cause
Measured: 3 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Through continuous monitoring and analysis of the safety data, the drug safety characteristics were evaluated, the suspected and unexpected serious adverse reactions and other major risks were identified in time, and appropriate measures were taken to fully control the risks and protect the safety of the subjects.
Measured: 3 years
Patient reported outcome (Quality of Life questionnaire of cancer patients)
EORTC Quality of Life-Core 30/18 questionnaire module
Measured: At the end of Cycle 1 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Sep 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Oesophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266480
- Sponsor's protocol ID
- ARL-ESCC
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No