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Gastric CancerPhase 3NCT05914610

Envollizumab Combined With Fruquintinib and SOX Versus SOX for Conversion Therapy in Advanced Gastric Cancer

A Phase 3 study testing Envolimab, Fruquintinib and Oxaliplatin in people with Gastric Cancer, run by Fujian Medical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

To investigate the clinical efficacy and safety of envollizumab combined with fruquintinib and SOX versus SOX in conversion therapy for patients with Her-2 negative, unresectable locally advanced gastric cancer. 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?
Envolimab, Fruquintinib and Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
1 Sep 2023to 30 Jul 2028
Phase
Phase 3
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

  • Age: 18-75 years of age;
  • Pathological (including histological or cytological) confirmation of gastric adenocarcinoma;
  • Before surgery, CT/MRI, PET-CT, if necessary, laparoscopic exploration to determine the clinical stage of T4bN0M0 and TanyN2-3M0, and determined by researchers that the local advanced patients can not be resectable;
  • At least one measurable detected by CT examination in accordance with the RECIST1.1
  • ECOG#Eastern Cooperative Oncology Group#PS#Performance Status#:0-1 scores;
  • The expected survival time is more than 3 months
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  • The main organ function is normal, which should meet the following criteria:
  • #1#blood routine examination standards should be met#no blood transfusion within 14 days#
  • a.HB≥ 100g/L b. WBC≥3×109/L c. ANC≥1.5×109/L d. PLT≥100×109/L #2#biochemical examination shall comply with the following criteria#
  • BIL#1.5 normal upper limit ULN
  • ALT and AST#2.5 ULN
  • Cr≤1 ULN#CCR#creatinine clearance rate##60ml/min(Cockcroft Gault formula)
  • Women of childbearing age must have a pregnancy test in 7 days before entering the group (in serum), and the results were negative, and willing to use appropriate contraception during the study period and the last 8 weeks after giving drug test; men should have the surgical sterilization, or adopt the appropriate contraceptive methods during the test and the last 8 weeks after giving drug test#
  • No other clinical studies were conducted before and during the treatment
  • Participants is willing to participate in this study, sign the informed consent, have good compliance, cooperate with follow-up

Who cannot join

  • Imaging or intraoperative exploration found patients with peritoneum, liver, lung and other distant metastases
  • Patients with allergies or suspected allergies to study drugs or similar drugs
  • Confirmed HER-2 positive patients
  • Other malignancies in the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix
  • Live vaccine was administered within 4 weeks prior to enrolling or possibly during the study period
  • Had an active autoimmune disease or a history of autoimmune disease within 4 weeks prior to enrollment
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  • Past recipients of allogeneic bone marrow transplants or organ transplants
  • Patient has any current disease or condition that affects drug absorption, or the patient is unable to take the drug orally
  • The blood pressure of patients with hypertension cannot be reduced to the normal range by the one antihypertensive drugs (systolic pressure ≥150 mmHg, diastolic pressure ≥100 mmHg) or hard to controled by two or more antihypertensive drugs
  • Patients are positive of urine protein (urine protein detection 2+ or above, or 24 hours urine protein quantitative >1.0g)
  • The patient currently has gastrointestinal diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresectosed tumors, or other conditions determined by researchers that may cause gastrointestinal bleeding or perforation
  • Patients with significant evidence or history of bleeding tendency within 3 months prior to enrollment (bleeding within 3 months >30 mL, hematemesis, black stool, blood in stool), hemoptysis (within 4 weeks >5 mL fresh blood) or a thromboembolic event (including stroke and/or transient ischemic attack) within 12 months
  • Cardiovascular disease of significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Grades for Congestive Heart Failure more than class II ; Ventricular arrhythmias requiring medical treatment; An electrocardiogram (ECG) showed a QT c interval ≥480 milliseconds
  • Active or uncontrolled severe infection (≥CTCAE grade 2 infection)
  • A history of human immunodeficiency virus (HIV) infection or clinically significant liver disease, including viral hepatitis [active HBV infection must be ruled out as a known carrier of hepatitis B virus (HBV), i.e. positive HBV DNA (>1×104 copies /mL or >2000 IU/ml); known hepatitis C virus infection (HCV) and HCV RNA positive (>1×103 copies /mL), or other hepatitis, cirrhosis]
  • The researchers consider those who were not suitable for inclusion

About this study

Official title: Envollizumab Combined With Fruquintinib and SOX Versus SOX for Conversion Therapy in Her-2 Negative Unresectable Locally Advanced Gastric Cancer: a National Multicenter Randomized Controlled Study

To investigate the clinical efficacy and safety of envollizumab combined with fruquintinib and SOX versus SOX in conversion therapy for patients with Her-2 negative, unresectable locally advanced gastric cancer.

Conditions
Gastric Cancer
Being tested
Envolimab, Fruquintinib, Oxaliplatin, Tegafur
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • EnvolimabDrug

    Envolizumab 300mg, D1, ih, Q3W 4-6cycles

  • FruquintinibDrug

    Fruquinitinib 3mg/d, QD, PO, D1-D14, Q3W 4-6cycles

  • OxaliplatinDrug

    Oxaliplatin 130 mg/m2, ivgtt 0-2h, D1, Q3W 4-6cycles

  • TegafurDrug

    Tegafur was calculated according to body surface area , P.O., bid, d1-d14#And the dosage according body surface area:<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; >1.5m2, 60mg every time Q3W 4-6cycles

Study groups in NCT05914610
Study groupRoleWhat they receive
Envolimab + fruquinitinib +SOX regimenExperimentalNot described
Receives: Drug: Envolimab; Drug: Fruquintinib; Drug: Oxaliplatin; Drug: Tegafur
SOX regimenActive comparatorNot described
Receives: Drug: Oxaliplatin; Drug: Tegafur

What is being measured

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

  1. Surgical conversion rate

    Defined as the proportion of patients who have undergone surgical resection after multidisciplinary assessment after completing 4-6 cycles of conversion therapy

    Measured: 2-3 months

Secondary outcomes (10)

  1. Pathological complete response (pCR)

    Measured as the proportion of participants with a pathological complete response at the time of definitive surgery.

    Measured: 4 months

  2. Median disease free survival (DFS) time

    The time from opreation to the time when only 50% of the individuals had no relapse or tumor progression

    Measured: 3 years

  3. 1-year DFS rate

    Measured: 1 year

  4. 3-year DFS rate

    Measured: 3 years

  5. Objective response rate (ORR)

    Defined as the percentage of the participants in the analysis population who had a confirmed patial response and complete reponse according to RECIST 1.1 based on investigator assessment

    Measured: 4 months

  6. Major pathological response rate (MPR)

    The proportion of participants with a major pathological response (mPR) at the time of definitive surgery.

    Measured: 4 months

  7. R0 resection rate

    Defined as no residue under the microscope after resection

    Measured: 2-3 month

  8. Median survival time

    The time from enrollment to the time when only 50% of the individuals alive

    Measured: 3 years

  9. Adverse event (AEs)

    Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The number of Participants with adverse events will be recorded at each treatment visit.

    Measured: 2 years

  10. Quality of life (QOL)

    The quality of life of patients during treatment is eveluated by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (V3.0)

    Measured: 2 years

Timeline

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

  1. First posted22 Jun 2023
  2. Study start1 Sep 2023 (estimated)
  3. Primary completion30 Jul 2025 (estimated)
  4. Study completion30 Jul 2028 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05914610
Sponsor's protocol ID
FUGES-028
Status last verified
Aug 2023
First submitted
27 May 2023
Last updated
25 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Envolimab, Fruquintinib and Oxaliplatin in people with Gastric Cancer, run by Fujian Medical University.

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 15 inclusion and 16 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: opening soon, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical conversion rate (time frame: 2-3 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 NCT05914610.

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 25 Aug 2023.

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