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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Clinical Study of Envafolimab Combined With Fruquintinib and Chemotherapy for Neoadjuvant Treatment of Gastric Cancer

Envafolimab Combined With Fruquintinib and Chemotherapy for Neoadjuvant Treatment of Gastric Cancer: a Single-arm, Open Clinical Study

Clinical Study of Envafolimab Combined With Fruquintinib and Chemotherapy for Neoadjuvant Treatment of Gastric Cancer (NCT06791083) is a Phase 2 interventional studying Gastric Cancer, sponsored by First Affiliated Hospital of Fujian Medical University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

To observe and evaluate the neoadjuvant treatment of Envafolimab combined with Fruquintinib and chemotherapy for locally advanced gastric/gastroesophageal junction carcinoma

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Gastric Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Have fully understood the study and voluntarily signed the willing to sign a consent form; 2. Aged 18-75 years (including 18 and 75 years); 3. Pathologically confirmed or potentially resectable locally advanced gastric/gastroesophageal junction adenocarcinoma (cT2-T4b, N+M0); 4. 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. 5. At least 1 measurable lesion according to RECIST v1.1 criteria; 6. United States Eastern Cancer Consortium (ECOG) Physical status score 0-1; BMI≥18; 7. Expected survival ≥12 weeks; 8. The functions of vital organs during the first 14 days of enrollment met the following requirements: - Absolute neutrophil count ≥1.5×109/L; - platelet count at least 80×109/L; - blood count (hemoglobin) at least 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; 9. Female subjects of childbearing age or male subjects 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 period; 10. Good compliance, cooperate with follow-up. Who Should NOT Join This Trial: 1. Known HER2-positive patients; 2. 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, immunotherapy, and other investigational drugs within 4 weeks prior to enrollment; 3. 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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Have fully understood the study and voluntarily signed the informed consent; 2. Aged 18-75 years (including 18 and 75 years); 3. Pathologically confirmed or potentially resectable locally advanced gastric/gastroesophageal junction adenocarcinoma (cT2-T4b, N+M0); 4. 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. 5. At least 1 measurable lesion according to RECIST v1.1 criteria; 6. United States Eastern Cancer Consortium (ECOG) Physical status score 0-1; BMI≥18; 7. Expected survival ≥12 weeks; 8. 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; 9. Female subjects of childbearing age or male subjects 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 period; 10. Good compliance, cooperate with follow-up. Exclusion Criteria: 1. Known HER2-positive patients; 2. 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, immunotherapy, and other investigational drugs within 4 weeks prior to enrollment; 3. 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; 4. Receive live vaccine within 4 weeks prior to enrollment or possibly during the study period; 5. Had active autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment; 6. Previously received allogeneic bone marrow transplantation or organ transplantation; 7. The patient has a current disease or condition that affects drug absorption, or the patient cannot take Fruquintinib orally; 8. Subjects who are allergic to the investigational drug or any of its adjuncts; 9. The investigator identified clinically significant electrolyte abnormalities; 10. 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; 11. 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 determined by researchers before enrollment; 12. 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 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months prior to admission; 13. 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 for men and 470 ms for women) within 6 months prior to first administration of the study drug (QTc interval Fridericia) Formula calculation); * New York Heart Association (NYHA) heart function Grade \> II or left ventricular ejection fraction (LVEF) \< 50%; 14. Known human immunodeficiency virus (HIV) infection; A known history of clinically significant liver disease, including viral hepatitis \[active HBV infection, i.e., positive HBV DNA (\>1×104 copies /mL or \>2000 IU/ml) must be excluded for a known hepatitis B virus (HBV) carrier; Known hepatitis C virus infection (HCV) and HCV RNA positive (\>1×103 copies /mL), or other hepatitis, cirrhosis\]; 16\. Women who are pregnant (positive pregnancy test before medication) or breastfeeding; 17. Two consecutive routine urine tests indicated urine protein ≥2+, and the urine protein volume \>1.0g within 24 hours of reexamination; 18. Patients with ascites or pleural effusion with clinical symptoms; 19. CTCAE V5.0 grade 1 or higher toxicity due to any previous anticancer treatment that is not resolved, excluding oxaliplatin induced alopecia, lymphocytopenia, and neurotoxicity ≤ grade 2; 20.Patients considered inappropriate for inclusion in this study.

Treatments Being Tested

DRUG

Envafolimab

150mg/m2 , IH, d1;Q3W

DRUG

Fruquintinib

5 mg ,po,QD,d1-d14;Q3W

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06791083), the sponsor (First Affiliated Hospital of Fujian Medical University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06791083 clinical trial studying?

To observe and evaluate the neoadjuvant treatment of Envafolimab combined with Fruquintinib and chemotherapy for locally advanced gastric/gastroesophageal junction carcinoma The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06791083?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06791083?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06791083. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06791083. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.