Actively Recruiting
Fruquintinib Combined With TAS102 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 combined with TAS102 for second-line treatment of advanced gastric cancer.
CONDITIONS
Official Title
Fruquintinib Combined With TAS102 for Advanced Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status of 0 or 1 with no worsening 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 with progression, or disease recurrence/progression within 6 months after adjuvant chemotherapy
- Presence of measurable lesions according to RECIST 1.1 criteria
- Adequate organ and bone marrow function meeting specific laboratory values for hemoglobin, neutrophils, platelets, bilirubin, liver enzymes, creatinine clearance, and urinary protein
- Normal coagulation function without active bleeding, including defined INR and APTT limits
- Negative pregnancy test for women of childbearing age and agreement to use contraception during and for 8 weeks after treatment; men must be sterilized or agree to contraception
- Expected survival of at least 3 months
- Voluntary informed consent to participate
- Expected good compliance with study protocol and follow-up for efficacy and adverse reactions
You will not qualify if you...
- Prior treatment with VEGFR inhibitors
- Previous paclitaxel therapy except as neoadjuvant or adjuvant therapy completed over 6 months before progression
- Receipt of live vaccine within 4 weeks before enrollment or during study
- Active or recent (within 4 weeks) autoimmune disease
- History of 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 medication
- Gastrointestinal diseases causing bleeding or perforation risk, such as active ulcers or unexcised tumors
- Significant bleeding events within 3 months or thromboembolic events within 12 months prior to enrollment
- Clinically significant cardiovascular disease within 6 months or specific heart function criteria not met
- Active or uncontrolled severe infection (grade 2 or higher)
- Known HIV infection or significant liver disease including active hepatitis B or C infection
- Any other medical condition or abnormality making the patient unsuitable for study participation as judged by investigators
- Investigator judgment deeming patient unsuitable for inclusion
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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