Actively Recruiting
Adebrelimab + Apatinib in SCLC Maintenance Therapy
Led by Tang-Du Hospital · Updated on 2024-06-26
60
Participants Needed
1
Research Sites
130 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
This prospective clinical study aims to evaluate and observe the efficacy and safety of Atezolizumab combined with Apatinib in maintenance therapy for extensive-stage small cell lung cancer using a single-arm trial design. The study is planned to be conducted in Shaanxi Province, China, with an initial target enrollment of 60 patients. The study commenced in February 2024, and recruitment is expected to conclude around December 2025, with the trial anticipated to end by December 2026. Assuming no occurrences such as withdrawal of informed consent by subjects, intolerable adverse drug reactions, or investigator-assessed unsuitability for further participation, each participant's estimated duration of study treatment will continue until radiographically confirmed tumor progression.
CONDITIONS
Official Title
Adebrelimab + Apatinib in SCLC Maintenance Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and provide signed informed consent
- Aged between 18 and 75 years
- Confirmed diagnosis of extensive-stage small cell lung cancer according to standard staging criteria
- ECOG performance status score between 0 and 2
- No disease progression after 4 to 6 cycles of platinum-based chemotherapy combined with Atezolizumab
- Non-hematologic adverse reactions recovered to grade 1 or better after induction therapy (except alopecia or skin pigment changes)
- Time from last induction treatment dose to maintenance therapy start is 6 weeks or less
- At least one measurable lesion according to RECIST 1.1
- Expected life expectancy of at least 3 months
- Adequate bone marrow function (ANC ≥ 1.5 x 10^9/L; platelets ≥ 100 x 10^9/L; hemoglobin > 80 g/L)
- Adequate renal function (creatinine ≤ 1.5x upper limit of normal or creatinine clearance > 50 ml/min)
- Adequate liver function (bilirubin ≤ 1.5x ULN, AST and ALT ≤ 3.0x ULN)
- Acceptable coagulation parameters (INR ≤ 1.55, PTT < 1.2x ULN)
- Women of childbearing potential must use contraception and have a negative pregnancy test before enrollment; men must agree to use contraception during and 6 months after the study
You will not qualify if you...
- Diagnosis of 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 swallowing difficulties or intestinal obstruction
- Major surgery, biopsies, or significant 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 other malignant tumors requiring treatment
- History of immunodeficiency or organ transplant
- Substance abuse or psychiatric disorders
- Severe or uncontrolled diseases such as poorly controlled hypertension, heart disease, severe respiratory disease, active infections, or decompensated liver disease
- Significant bleeding or bleeding tendencies within 3 months prior
- Venous or arterial thrombotic events within 6 months prior
- Abnormal coagulation or bleeding tendency requiring anticoagulation beyond allowed prophylaxis
- Inability to comply with study procedures or restrictions as judged by the investigator
AI-Screening
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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
CONTACT
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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