Clinical Study of Adbelimumab in the Adjuvant Treatment of Esophageal Squamous Cell Carcinoma.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adebrelizumab.
- Who it may be relevant to
- Registry conditions: Squamous Oesophageal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomised, Controlled Clinical Study of Adebrelizumab for the Adjuvant Treatment of Esophageal Squamous Cell Cancer.
Overview
Evaluating the efficacy and safety of adebrelizumab for the adjuvant treatment of esophageal squamous cell cancer.
Interventions
- Drug Adebrelizumab
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)
Primary outcome measures
- DFS [Time frame: 3 years]
Secondary outcome measures (3)
- OS [Time frame: 3 years]
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time frame: 3 years]
- Patient reported outcome (Quality of Life questionnaire of cancer patients) [Time frame: At the end of Cycle 1 (each cycle is 21 days)]
Eligibility criteria
Inclusion criteria
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:
- 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.
Exclusion criteria
- 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;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- 12, Jiankang road, Chang'an District, Shijiazhuang, Hebei 050000, China — Shijiazhuang
Identifiers
NCT: NCT07266480 · ARL-ESCC