Actively Recruiting
Adebrelimab and Fruquintinib Combined With Paclitaxel/Albumin Paclitaxel for Advanced Gastric Cancer After PD-1 Antibody Failed
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 After PD-1 Antibody Failed
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status 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 for this cancer and progressed, or adjuvant chemotherapy with progression or recurrence within 6 months
- First-line treatment with PD-1 antibodies with progression-free survival longer than 9 months
- Measurable lesions according to RECIST 1.1 criteria
- Adequate organ and bone marrow function as defined by specific laboratory values
- Normal coagulation function without active bleeding
- Women of childbearing age must have a negative pregnancy test within 14 days prior to enrollment and agree to use contraception during observation and 8 weeks after last dose; men must be surgically sterilized or agree to contraception during observation and 8 weeks after last dose
- Expected survival of at least 3 months
- Voluntary informed consent signed
- Expected good compliance with protocol requirements for efficacy and adverse reaction follow-up
You will not qualify if you...
- Previous treatment with VEGFR inhibitors
- Prior paclitaxel therapy except if given as neoadjuvant or adjuvant therapy ending more than 6 months before disease progression
- Received live vaccine within 4 weeks before enrollment or possibly during study
- Active or recent (within 4 weeks) autoimmune disease
- Previous allogeneic bone marrow or organ transplantation
- Uncontrolled hypertension defined as systolic ≥150 mmHg or diastolic ≥90 mmHg
- Conditions affecting drug absorption or inability to take oral drugs
- Active gastrointestinal diseases causing bleeding or risk of bleeding
- Significant bleeding tendency or thromboembolic events within specified timeframes
- Recent clinically significant cardiovascular disease or heart failure NYHA class >2
- Active or uncontrolled severe infection
- Known HIV infection or significant liver disease including active hepatitis B or C
- Other medical conditions or abnormalities that increase risk or interfere with study as judged by investigator
- Investigator's judgment deeming patient unsuitable for study inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here