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New treatment option for Gastric Cancer
Official title Clinical Study of Envafolimab Combined With Fruquintinib and Chemotherapy for Neoadjuvant Treatment of Gastric Cancer
ClinicalTrials.gov ID: NCT06791083
What this study is testing
What is Envafolimab?
Envafolimab is an investigational medicine, being studied as a potential treatment for gastric cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To observe and evaluate the neoadjuvant treatment of Envafolimab combined with Fruquintinib and chemotherapy for locally advanced gastric/gastroesophageal junction carcinoma
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- At least 1 measurable lesion according to RECIST v1.1 criteria;
You likely can't join if
- Known HER2-positive patients;
- Participated in other drug clinical trials and received at least one drug therapy within 4 weeks prior to enrollment or received other systemic...
- Had other malignancies within 5 years prior to admission, except basal cell or squamous cell carcinoma of the skin after radical surgery, or...
- Receive live vaccine within 4 weeks prior to enrollment or possibly during the study period;
- Had active autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment;
- Previously received allogeneic bone marrow transplantation or organ transplantation;
See the full eligibility criteria
- 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;
- United States Eastern Cancer Consortium (ECOG) Physical status score 0-1; BMI≥18;
- Expected survival ≥12 weeks;
- The functions of vital organs during the first 14 days of enrollment met the following requirements:
- Absolute neutrophil count ≥1.5×109/L;
- Platelet ≥80×109/L;
- Hemoglobin ≥90g/L;
- Total bilirubin \< 1.5 ULN; ALT and AST \< 2.5 ULN (\< 5 ULN in patients with liver metastasis);
- Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr)≥60ml/min;
- endogenous creatinine clearance \> 50ml/min;
- Female people of childbearing age or male people whose sexual partner is a female of childbearing age should take effective contraceptive measures during the whole treatment period and 6 months after the treatment...
- Good compliance, cooperate with follow-up.
- Known HER2-positive patients;
- Participated in other drug clinical trials and received at least one drug therapy within 4 weeks prior to enrollment or received other systemic anti-tumor therapy, including chemotherapy, signal transduction inhibitors...
- Had other malignancies within 5 years prior to admission, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
- Receive live vaccine within 4 weeks prior to enrollment or possibly during the study period;
- Had active autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment;
- Previously received allogeneic bone marrow transplantation or organ transplantation;
- The patient has a current disease or condition that affects drug absorption, or the patient cannot take Fruquintinib orally;
- people who are allergic to the investigational drug or any of its adjuncts;
- The investigator identified clinically significant electrolyte abnormalities;
- Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg;
- Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unresectable tumors, or other conditions that may cause gastrointestinal bleeding or perforation as...
- Patients with significant evidence or history of bleeding tendency within 3 months (bleeding \>30 mL within 3 months, accompanied by hematemesis, stool, and blood in the stool), hemoptysis (\>5 mL of fresh blood within...
- History of severe cardiovascular and cerebrovascular diseases:
- Cerebrovascular accident (excluding lacunar infarction, minor cerebral ischemia, or transient ischemic attack), myocardial infarction, unstable angina, and poorly controlled arrhythmias (including QTc interval ≥ 450ms...
- New York Heart Association (NYHA) heart function Grade \> II or left ventricular ejection fraction (LVEF) \< 50%;
- Known human immunodeficiency virus (HIV) infection; A known history of clinically significant liver disease, including viral hepatitis [active HBV infection, i.e., positive HBV DNA (\>1×104 copies /mL or \>2000 IU/ml)...
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.