Status:
NOT_YET_RECRUITING
A Real-world Study of Adebrelimab-based Combination Regimens in the Treatment of Advanced Solid Tumors
Lead Sponsor:
Tianjin First Central Hospital
Conditions:
Non-Small Cell Lung Cancer
Small Cell Lung Cancer
Eligibility:
All Genders
18-80 years
Brief Summary
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 tumo...
Detailed Description
This prospective, multicenter, non-interventional, observational, real-world study aims to evaluate the safety and efficacy of adebrelimab in patients with advanced solid tumors. The study is expected...
Eligibility Criteria
Inclusion
- 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;
- Age 18-80 years;
- Patients deemed by the investigator to be eligible for adebrelimab monotherapy or combination therapy;
- Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the first dose of study drug (Cycle 1, Day 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Females and males of childbearing potential must agree to use appropriate contraceptive methods or undergo surgical sterilization during the trial and within 90 days after the last dose of the trial drug.
- Ability to comply with study and follow-up procedures.
Exclusion
- 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;
- Patients who are deemed by the investigator to be unsuitable for participation in this study in any other circumstances, including but not limited to the following: (1) Patients with autoimmune diseases (AIDs), especially neurological AIDs, or AIDs that are moderate to severe or in active stage and cannot be controlled by immunosuppressants or require high-dose immunosuppressants to control symptoms; (2) Patients with tuberculosis infection, active tuberculosis, and suspected active TB should be examined by chest X-ray, sputum, and clinical symptoms and signs to exclude; (3) The patient has previously received or is about to receive solid organ transplantation or hematopoietic stem cell transplantation; (4) The patient needs to use large doses of antibiotics, glucocorticoids, proton pump inhibitors and other drugs for a long time.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07173244
Start Date
September 15 2025
End Date
September 1 2029
Last Update
September 15 2025
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