Actively Recruiting
Adebrelimab and Fruquintinib Combined With Paclitaxel/Albumin Paclitaxel for Advanced Gastric Cancer
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2023-10-26
30
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single-center, open, single-arm clinical study to observe and evaluate the efficacy and safety of Fruquintinib and Adebrelimab combined with paclitaxel/albumin paclitaxel for second-line treatment of advanced gastric cancer.
CONDITIONS
Official Title
Adebrelimab and Fruquintinib Combined With Paclitaxel/Albumin Paclitaxel for Advanced Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status of 0-1 without deterioration within 7 days
- Histologically confirmed metastatic or unresectable locally advanced gastric cancer or gastroesophageal junction adenocarcinoma
- Previously received one systemic chemotherapy regimen with disease progression, or recurrence within 6 months after adjuvant chemotherapy
- No prior exposure to PD-1/PD-L1 inhibitors
- Presence of measurable lesions according to RECIST 1.1 criteria
- Adequate organ and bone marrow function meeting specified laboratory values (e.g., hemoglobin, neutrophils, platelets, liver enzymes, creatinine clearance)
- Normal coagulation function without active bleeding
- Negative pregnancy test for women of childbearing age and use of effective contraception; men must use contraception or be surgically sterilized
- Expected survival of at least 3 months
- Voluntary informed consent
- Ability to comply with study protocol and follow-up
You will not qualify if you...
- Previous treatment with VEGFR inhibitors
- Prior paclitaxel therapy except if given as neoadjuvant or adjuvant therapy completed more than 6 months before progression
- Receipt of live vaccine within 4 weeks prior to enrollment or during the study
- Active autoimmune disease or history within 4 weeks prior to enrollment
- Previous allogeneic bone marrow or organ transplantation
- Uncontrolled hypertension defined as systolic ≥150 mmHg or diastolic ≥90 mmHg despite medication
- Conditions affecting drug absorption or inability to take oral medication
- Active gastrointestinal diseases causing bleeding or risk of perforation
- Significant bleeding events or thromboembolic events within specified timeframes
- Clinically significant cardiovascular diseases including recent myocardial infarction, severe angina, or heart failure NYHA class greater than 2
- Active or uncontrolled severe infection (grade 2 or higher)
- Known HIV infection or significant liver disease including active hepatitis B or C
- Any other medical or laboratory abnormalities or conditions deemed unsuitable for study participation by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
T
Ting Deng, MD
CONTACT
J
Jiayu Zhang, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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