Gastrointestinal Cancers, Non-Small Cell Lung Cancer, Small Cell Lung Cancer
Conditions
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 tumors.
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 to enroll 300 patients with advanced solid tumors. Information on demographics, previous treatment history, adebrelimab-containing treatment regimens, clinical outcomes, and adverse events will be collected for all enrolled patients. Patients must have a clinically confirmed diagnosis of locally advanced, recurrent, or metastatic cancer, including but not limited to non-small cell lung cancer, small cell lung cancer, and gastrointestinal cancers (esophageal, gastric, liver, biliary, pancreatic, and intestinal cancers). Patients had already decided to receive adebrelimab before enrollment. Based on their tumor type, stage, and previous treatment history, they were assigned to one of two cohorts: Cohort 1: First-line treatment with adebrelimab combined with etoposide and carboplatin for extensive-stage small cell lung cancer; Cohort 2: Other solid tumors treated with an adebrelimab-based regimen (excluding central nervous system, urinary, bone, soft tissue sarcomas, and skin tumors such as melanoma). The adebrelimab regimen in Cohort 1 was 1200 mg intravenously infused every 21 days. The adebrelimab regimen in Cohort 2 was based on the instructions. Patients were followed up until loss to follow-up, death, withdrawal of consent, or study termination/closure, whichever occurred first. This study was a non-interventional, real-world study. The diagnosis and treatment process, visits, and examinations were based on routine clinical experience, and no intervention was made on patients' medication choices. The data for this study were primarily sourced from patients' daily diagnosis and treatment records.
Interventions
DRUGAdebrelimab
adebrelimab-based regimen
Sponsors
Tianjin First Central Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent and voluntarily enrolled in this study; 2. Histologically or cytologically confirmed extensive-stage small cell lung cancer; 3. 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; 4. 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; 5. Age 18-80 years; 6. Patients deemed by the investigator to be eligible for adebrelimab monotherapy or combination therapy; 7. 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. 8. Ability to comply with study and follow-up procedures.
Exclusion criteria
1. Women who have been confirmed to be pregnant or breastfeeding; 2. 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; 3. Patients with a history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 4. Patients with known allergies to adebrelimab or any of its drugs and excipients; 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of treatment-related adverse reactions(TRAE)/immunotherapy-related adverse reactions/(irAE) and grade ≥ 3 TRAE/irAE | Through study completion, an average of 1 year | The rate of treatment-related adverse reactions(TRAE)/immunotherapy-related adverse reactions/(irAE) and grade ≥ 3 TRAE/irAE, based on CTAE 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of treatment Mode | Through study completion, an average of 1 year | The detailed treatment regimen used for enrolled patients |
| The rate of Treatment efficacy | Through study completion, an average of 1 year | Statistical analysis of disease-free survival(PFS, median PFS, 1-year PFS rate et.al ) for different treatment regimens |
Contacts
Primary ContactWei Jiang Tianjin First Central Hospital, Professor
Outcome results
None listed