Actively Recruiting
Envafolimab Combined With Fruquintinib and Chemotherapy for Pre-Surgery Treatment of Locally Advanced Gastric and Gastroesophageal Junction Cancer A Single-Arm, Open Clinical Study
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
Researchers are evaluating the neoadjuvant treatment combining Envafolimab, Fruquintinib, and chemotherapy for patients with locally advanced gastric or gastroesophageal junction adenocarcinoma. This Phase 2 study aims to observe and assess outcomes such as the major pathological response rate, complete and overall pathological response rates, objective response rate, R0 resection rate, disease-free survival, overall survival, and safety. The study also explores the relationship between tumor blood vessel growth and clinical outcomes using immunohistochemical markers like CD31, CD3, and CD8. Participants receive Envafolimab at a dose of 150 mg/m2 intravenously on day 1 every three weeks, combined with Fruquintinib 5 mg taken orally once daily from days 1 to 14 in a 21-day cycle. Chemotherapy is also administered as part of the neoadjuvant treatment, although specific chemotherapy details are not provided. The study is a single-arm, open-label trial focusing on this combination therapy before surgery. During the study, participants undergo regular assessments including imaging to measure tumor response according to RECIST v1.1 criteria, pathological evaluations after surgery, and laboratory tests to monitor vital organ function. Researchers track survival outcomes and safety over up to 12 months. Participants are expected to comply with follow-up visits and contraceptive measures during treatment and for six months afterward. The total study duration and follow-up periods are designed to carefully evaluate treatment effects and patient outcomes.
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
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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
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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