A Real-world Study of Adebrelimab-based Combination Regimens in the Treatment of Advanced Solid Tumors
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorTianjin First Central Hospital
About this trial
This prospective, multicenter, non-interventional, observational, real-world study was designed to evaluate the safety and efficacy of an adebrelimab-based regimen in patients with advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent and voluntarily enrolled in this study;
Histologically or cytologically confirmed extensive-stage small cell lung cancer;
Patients with other types of advanced solid tumors confirmed by histology or cytology; patients who, based on currently available data, the investigator believes may benefit from adebrelimab treatment may also be considered for enrollment;
Patients in Cohort 1 who experience disease progression and whose second-line treatment options, as assessed by the investigator, include adebrelimab in combination therapy may be enrolled in Cohort 2;
Disqualifiers
Women who have been confirmed to be pregnant or breastfeeding;
Patients with histologically or cytologically confirmed central nervous system tumors, urinary system tumors, reproductive system tumors, bone tumors, soft tissue sarcomas, melanomas and other skin tumors;
Patients with a history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
Patients with known allergies to adebrelimab or any of its drugs and excipients;
Trial population
Patients with locally advanced/recurrent or metastatic solid tumors were eligible for adebrelimab-based monotherapy or combination therapy at the investigator's discretion at the time of enrollment. Patients with central nervous system tumors, urinary system tumors, reproductive system tumors, bone tumors, soft tissue sarcomas, melanoma, and other skin tumors were excluded.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Adebrelimab
Drugadebrelimab-based regimen
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Arm 11 intervention
Trial outcomes
Primary outcomes
1
The rate of treatment-related adverse reactions(TRAE)/immunotherapy-related adverse reactions/(irAE) and grade ≥ 3 TRAE/irAE
The rate of treatment-related adverse reactions(TRAE)/immunotherapy-related adverse reactions/(irAE) and grade ≥ 3 TRAE/irAE, based on CTAE 5.0
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
The rate of treatment Mode
The detailed treatment regimen used for enrolled patients
Time frame
Through study completion, an average of 1 year2
The rate of treatment Mode
The duration of drug treatment (DOT) of eroolled patients
Time frame
Through study completion, an average of 1 year3
The rate of Treatment efficacy
Statistical analysis of disease-free survival(PFS, median PFS, 1-year PFS rate et.al ) for different treatment regimens
Time frame
Through study completion, an average of 1 year4
The rate of Treatment efficacy
Statistics of overall survival(OS, median OS, 1-year OS rate et al.) of different treatment regimens
Time frame
Through study completion, an average of 1 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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