Actively Recruiting
Clinical Study of Envafolimab Combined With Fruquintinib and Chemotherapy for Neoadjuvant Treatment of Gastric Cancer
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2025-01-24
40
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To observe and evaluate the neoadjuvant treatment of Envafolimab combined with Fruquintinib and chemotherapy for locally advanced gastric/gastroesophageal junction carcinoma
CONDITIONS
Official Title
Clinical Study of Envafolimab Combined With Fruquintinib and Chemotherapy for Neoadjuvant Treatment of Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have fully understood the study and voluntarily signed the informed consent
- Aged 18-75 years (including 18 and 75 years)
- Pathologically confirmed or potentially resectable locally advanced gastric/gastroesophageal junction adenocarcinoma (cT2-T4b, N+M0)
- If bone metastasis is suspected, a bone scan should be performed
- If peritoneal metastasis is suspected, abdominal examination should be performed to rule out distant metastasis
- At least 1 measurable lesion according to RECIST v1.1 criteria
- Eastern Cancer Consortium (ECOG) Physical status score 0-1; BMI≥18
- Expected survival ≥12 weeks
- Vital organ functions within 14 days of enrollment meet specified blood count and biochemical criteria
- Female subjects of childbearing age or male subjects with female partners of childbearing age must use effective contraception during treatment and for 6 months after
- Good compliance and willingness to cooperate with follow-up
You will not qualify if you...
- Known HER2-positive patients
- Participation in other drug clinical trials or receipt of systemic anti-tumor therapy within 4 weeks prior to enrollment
- Other malignancies within 5 years prior to admission, except certain skin cancers and cervical carcinoma in situ
- Receipt of live vaccine within 4 weeks prior to enrollment or possibly during the study
- Active or recent autoimmune disease within 4 weeks prior to enrollment
- Previous allogeneic bone marrow or organ transplantation
- Conditions affecting drug absorption or inability to take Fruquintinib orally
- Allergy to investigational drugs or their components
- Clinically significant electrolyte abnormalities
- Uncontrolled hypertension defined as systolic ≥150 mmHg or diastolic ≥100 mmHg prior to enrollment
- Active gastrointestinal diseases or bleeding risks as determined by researchers
- Significant bleeding history within 3 months or thromboembolic events within 12 months prior to admission
- Severe cardiovascular or cerebrovascular disease within 6 months prior to first study drug administration
- Known HIV infection or significant liver disease including active hepatitis B or C infection
- Pregnant or breastfeeding women
- Significant proteinuria or clinical symptoms of ascites or pleural effusion
- Unresolved toxicity from previous anticancer treatment except specific low-grade conditions
- Patients considered inappropriate for inclusion by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Actively Recruiting
Research Team
J
Jianxin Ye Ye
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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