Actively Recruiting
A Study of PD-1 Inhibitors Combined With Fruquintinib and Chemotherapy in First-line Treatment of HER2-negative Advanced G/GEJ Cancer
Led by Fudan University · Updated on 2023-12-06
58
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, single-arm, single-center clinical study to investigate the safety and efficacy of fuquinitinib combined with PD-1 inhibitors and first-line chemotherapy in the treatment of inoperable HER2-negative advanced GC/GEJC. Eligible enrolled patients received 6 cycles of combined treatment with fuquinitinib combined with PD-1 inhibitor and chemotherapy (XELOX/SOX) regimen. Maintenance treatment was fuquinitinib combined with PD-1 inhibitor and Teghio/capecitabine until disease progression or toxicity became intolerable. The longest duration of PD-1 inhibitor treatment is 24 months.
CONDITIONS
Official Title
A Study of PD-1 Inhibitors Combined With Fruquintinib and Chemotherapy in First-line Treatment of HER2-negative Advanced G/GEJ Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand the study and voluntarily sign informed consent
- Aged 18 to 80 years, male or female
- Have unresectable advanced or metastatic gastric or esophagogastric junction adenocarcinoma confirmed by pathology or histology
- ECOG physical status of 0 or 1
- Expected survival of at least 3 months
- No prior anti-tumor therapy for unresectable advanced or metastatic gastric cancer; prior adjuvant therapy allowed if more than 6 months have passed since last treatment
- At least one measurable lesion meeting RECIST v1.1 criteria
- Vital organ functions meet specified blood count, liver, kidney, heart, thyroid, and coagulation parameters
- Negative pregnancy test for women of childbearing potential
You will not qualify if you...
- Known HER2-positive status (immunohistochemical 3+ or 2+ with FISH positive)
- Other malignancies within 5 years except certain skin and cervical cancers
- Previous allogeneic bone marrow or organ transplantation
- Severe cardiovascular disease within 6 months
- Allergy to investigational drug or its components
- Uncontrolled hypertension (systolic ≥150 mmHg or diastolic ≥90 mmHg)
- Conditions affecting drug absorption or inability to take oral medications
- Active gastrointestinal diseases causing bleeding or risk of perforation
- Significant bleeding or thromboembolic events within specified timeframes
- Clinically significant cardiovascular disease or heart failure above NYHA level 2
- Active or uncontrolled severe infection
- Known HIV infection or active hepatitis B or C
- Active or history of certain autoimmune diseases not controlled or requiring intervention
- Recent use of immunosuppressive or systemic hormone therapy for immunosuppression
- Interstitial lung disease, pneumonia, pulmonary fibrosis, or radiation pneumonia
- Pregnant or breastfeeding women
- Any other medical or laboratory condition judged unsuitable by the investigator
- Significant proteinuria (urinary protein ≥2+ or 24-hour urinary protein ≥1.0 g)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University ShangHai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
X
Xiaodong Zhu
CONTACT
C
Chenchen Wang
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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