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Gastric CancerPhase 2NCT06791083

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

A Phase 2 study testing Envafolimab and Fruquintinib in people with Gastric Cancer, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer
What is being tested?
Envafolimab and Fruquintinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
20 Jun 2024to May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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 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;
  • Good compliance, cooperate with follow-up.

Who cannot join

  • 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, immunotherapy, and other investigational drugs within 4 weeks prior to enrollment;
  • 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;
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  • The patient has a current disease or condition that affects drug absorption, or the patient cannot take Fruquintinib orally;
  • Subjects 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 determined by researchers before enrollment;
  • 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;
  • 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%;
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jianxin Ye Ye contact

13809553280

yejianxinfuyi@126.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

    The First Affiliated Hospital FJMU-FAH of Fujian Medical University, +86 0591 87981029, fjydfyjg@163.com

    Recruiting

Other trials in China

About this study

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

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

Read the detailed description

This study observed and evaluated the major pathological response rate (MPR), pathological complete response rate (pCR), pathological response rate (pRR), objective response rate (ORR), R0 removal rate, disease-free survival (DFS) of Envafolimab combined with Fruquintinib and chemotherapy in neoadjuvant therapy for locally advanced gastric/gastroesophageal junctional cancer. Overall survival (OS) and security. The relationship between tumor angiogenesis and lymphangiogenesis and clinical outcome of patients (including but not limited to immunohistochemical detection of CD31, CD3, CD8, etc.) was also explored.

Conditions
Gastric Cancer
Being tested
Envafolimab, Fruquintinib
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnvafolimabDrug

    150mg/m2 , IH， d1；Q3W

  • FruquintinibDrug

    5 mg ，po，QD，d1-d14；Q3W

Study groups in NCT06791083
Study groupRoleWhat they receive
Envafolimab combined with Fruquintinib and chemotherapyExperimentalNot described
Receives: Drug: Envafolimab; Drug: Fruquintinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major pathological response rate (MPR)

    MPR is defined as the proportion of neoadjuvant therapy induced tumor regression with pathologically remaining tumor < 10%

    Measured: up to 12 months

Secondary outcomes (6)

  1. Pathological complete response rate (pCR)

    pCR is defined as the proportion of patients who do not have residual cancer cells on pathological examination after treatment

    Measured: up to 12 months

  2. Pathological response rate (pRR)

    pRR is defined as the proportion of patients whose pathologic examination after treatment found no cancer cells remaining or whose cancer cells remaining within a pre-specified value range

    Measured: up to 12 months

  3. Objective response rate (ORR)

    ORR is defined as the proportion of patients whose best overall assessment is a complete or partial response.

    Measured: up to 12 months

  4. Disease-free survival (DFS)

    DFS is defined as the time between a patient's enrollment and the onset of tumor recurrence or death from any cause

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 years

  5. Overall survival (OS)

    OS is defined as the time until a patient is enrolled and dies from any cause

    Measured: From date of randomization until the date of death from any cause, assessed up to 10 years

  6. R0 removal rate

    R0 resection rate was defined as the proportion of patients with complete resection of the tumor and a negative submicroscopic margin, i.e. no residual tumor

    Measured: up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2025
  2. Study start20 Jun 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06791083
Sponsor's protocol ID
HMPL-013-E1-GC003
Status last verified
Jan 2025
First submitted
20 Jun 2024
Last updated
24 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Envafolimab and Fruquintinib in people with Gastric Cancer, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jianxin Ye Ye (13809553280, yejianxinfuyi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major pathological response rate (MPR) (time frame: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06791083.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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