Actively Recruiting
Observational Study on the Efficacy and Safety of Adebrelimab Combined With Apatinib in Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer
Led by Tang-Du Hospital · Updated on 2024-06-26
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
T
Tang-Du Hospital
Lead Sponsor
J
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Adebrelimab combined with Apatinib as a maintenance treatment for patients with extensive-stage small cell lung cancer (SCLC). This phase 2 clinical trial uses a single-arm design to observe how well this drug combination works in preventing cancer progression after initial chemotherapy and immunotherapy. The study is planned to enroll 60 patients in Shaanxi Province, China, beginning in June 2024 and expected to finish by December 2026. Participants receive treatment cycles lasting three weeks each. Adebrelimab is given intravenously at 1200 mg on day 1 of each cycle, every three weeks. Apatinib is taken orally at 250 mg daily for the first 14 days of the cycle, followed by a one-week break. Treatment timing allows for a window of plus or minus 15 days. Patients undergo regular assessments including vital signs, physical exams, laboratory tests, and performance status evaluations to monitor tolerability and decide on treatment continuation. Throughout the study, researchers will track progression-free survival, overall survival, response rates, and duration of response up to several years. Patients will be followed until tumor progression is confirmed by imaging or other criteria. Safety and side effects will also be monitored closely. The total participation duration varies but is expected to continue until disease progression or other study stopping criteria, with follow-up assessments occurring at regular intervals.
CONDITIONS
Brief Title
Adebrelimab + Apatinib in SCLC Maintenance Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent and good compliance for follow-up
- Age between 18 and 75 years old
- Histologically or cytologically confirmed extensive-stage small cell lung cancer according to AJCC 8th edition or VALG phase II staging
- ECOG performance status score of 0 to 2
- No disease progression after 4-6 cycles of platinum-based chemotherapy combined with Atezolizumab induction therapy
- Non-hematologic adverse reactions recovered to grade 1 or better after induction therapy (except alopecia or skin changes)
- Time from end of induction treatment to maintenance treatment initiation is 6 weeks or less
- At least one measurable lesion by RECIST 1.1
- Expected life expectancy of at least 3 months
- Normal major organ function including bone marrow, renal, liver, and coagulation parameters
- Women of childbearing potential and men must agree to use contraception during the study and for 6 months after
- Negative pregnancy test within 1 week before enrollment and non-lactating status for women
You will not qualify if you...
- Limited-stage small cell lung cancer
- Mixed-type small cell lung cancer
- Prior use of anti-angiogenic drugs or unsuitable for anti-angiogenic therapy
- Central tumors invading major blood vessels with bleeding risk
- Conditions affecting oral medication intake such as dysphagia or chronic diarrhea
- Major surgery, incisional biopsy, or trauma within 4 weeks before enrollment
- Participation in another investigational drug trial within 4 weeks
- Untreated or symptomatic brain metastases or spinal cord compression
- Active malignant tumors requiring treatment
- History of immunodeficiency, HIV positivity, or organ transplant
- History of substance abuse or psychiatric disorders
- Severe or uncontrolled diseases including poorly controlled hypertension, ischemic heart disease, arrhythmias, or heart failure
- Decompensated diabetes or contraindications to high-dose corticosteroids
- Severe respiratory diseases requiring hospitalization
- Active or uncontrolled infections
- Uncontrolled pleural, pericardial effusions or ascites requiring repeated drainage
- Liver cirrhosis, active hepatitis, or chronic hepatitis requiring treatment
- Renal insufficiency with proteinuria above defined limits
- Significant recent bleeding or bleeding tendency
- Venous or arterial thrombotic events within 6 months
- Abnormal coagulation function or ongoing anticoagulant therapy beyond allowed prophylactic doses
- Inability to comply with study procedures or requirements as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive Adebrelimab combined with Apatinib in maintenance therapy for extensive-stage small cell lung cancer. Each treatment cycle lasts 3 weeks with Adebrelimab administered on day 1 and Apatinib taken daily for 14 days followed by a 7-day break. Participants undergo assessments including vital signs, physical exams, laboratory tests, and performance status evaluations to monitor treatment tolerability.
Visits every 3 weeks coinciding with treatment cycles
Trial Site Locations
Total: 1 location
1
Tangdu Hospital Affiliated to the Fourth Military Medical University
Xi'an, Shannxi, China, 710038
Actively Recruiting
Research Team
J
Jie Min, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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