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New treatment option for Gastric Cancer/Adenocarcinoma of Esophagogastric Junction
Official title A Study of PD-1 Inhibitors Combined With Fruquintinib and Chemotherapy in First-line Treatment of HER2-negative Advanced G/GEJ Cancer
ClinicalTrials.gov ID: NCT06158919
What this study is testing
What is Fruquintinib、Nivolumab、Sintilimab、Oxaliplatin、Teysuno、Capecitabine?
Fruquintinib、Nivolumab、Sintilimab、Oxaliplatin、Teysuno、Capecitabine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric cancer/adenocarcinoma of esophagogastric junction.
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
- 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.
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 80
You may be able to join if
- Have fully understood the study and voluntarily signed the informed consent; 2.18-80 years old (including 18 and 80 years old), male or female; 3\...
- Absolute neutrophil count ≥1.5×109/L, white blood cell ≥3.0×109/L;
- Platelet ≥90×109/L;
- Hemoglobin ≥8g/dL;
- Total bilirubin TBIL≤1.5 times ULN; ⑤ALT and AST≤2.5 times ULN; ⑥ Urea/urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN (and creatinine clearance...
You likely can't join if
- 1\. Patients with known HER-2 status (immunohistochemical 3+, or immunohistochemical 2+\&FISH positive);
- 2\. Had other malignancies within 5 years prior to admission, except basal cell or squamous cell carcinoma of the skin after radical surgery, or...
- 3\. Previously received allogeneic bone marrow transplantation or organ transplantation;
- 4\. Severe cardiovascular disease, including unstable angina pectoris or myocardial infarction, in the 6 months prior to enrollment;
- 5\. people who are allergic to the investigational drug or any of its adjuncts;
- 6\. Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmHg and/or diastolic blood...
See the full eligibility criteria
- Have fully understood the study and voluntarily signed the informed consent; 2.18-80 years old (including 18 and 80 years old), male or female; 3\. Patients with unresectable advanced or metastatic...
- Absolute neutrophil count ≥1.5×109/L, white blood cell ≥3.0×109/L;
- Platelet ≥90×109/L;
- Hemoglobin ≥8g/dL;
- Total bilirubin TBIL≤1.5 times ULN; ⑤ALT and AST≤2.5 times ULN; ⑥ Urea/urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN (and creatinine clearance (CCr) ≥ 50mL/min); ⑦Left ventricular ejection fraction (LVEF) ≥50%...
- 1\. Patients with known HER-2 status (immunohistochemical 3+, or immunohistochemical 2+\&FISH positive);
- 2\. 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;
- 3\. Previously received allogeneic bone marrow transplantation or organ transplantation;
- 4\. Severe cardiovascular disease, including unstable angina pectoris or myocardial infarction, in the 6 months prior to enrollment;
- 5\. people who are allergic to the investigational drug or any of its adjuncts;
- 6\. Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg;
- 7\. Had any disease or condition affecting drug absorption before enrollment, or the patient could not take drugs orally;
- 8\. Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unexcised tumors, or other conditions that may cause gastrointestinal bleeding or perforation as...
- 9\. Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding within 3 months \>30 mL, hematemesis, stool, stool blood), hemoptysis (within 4 weeks \>5 mL of fresh...
- 10\. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; New...
- 11\. Active or uncontrolled severe infection (≥CTCAE v5.0 grade 2 infection);
- 12\. Known human immunodeficiency virus (HIV) infection. Known history of clinically significant liver disease, including viral hepatitis [Known hepatitis B virus (HBV) carriers must rule out active HBV infection, i.e...
- 13\. The patient has any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis...
- 14\. Immunosuppressive use of immunosuppressants or systemic hormone therapy within 7 days prior to enrollment for immunosuppressive purposes (dose \>10mg/ day prednisone or other therapeutic hormone).
- 15\. Currently suffering from interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease, radiation pneumonia;
- 16\. Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
- 17\. Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, which, in the investigator's judgment, reasonably suspects that the patient has a medical...
- 18\. Urine routine indicated urinary protein ≥2+, and 24-hour urinary protein volume ≥1.0g;
- Patients considered inappropriate for inclusion in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, 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.