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AzTrials

Gastric CancerPhase 2NCT05721651

Efficacy and Safety of Fruquintinib in Combination With PD-1 Inhibitors as First-line Maintenance Therapy for Advanced HER-2 Negative Gastric Cancer: a Single-arm, Prospective, Exploratory Clinical Study

A Phase 2 study testing Fruquintinib+PD-1 in people with Gastric Cancer, run by Wu Jun at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Maintenance therapy is very important in advanced HER-2 negative gastric cancer, and immune monotherapy has no obvious benefit in the first-line maintenance treatment of advanced gastric cancer； Fruquintinib is a potent small-molecule VEGFR inhibitor with high kinase selectivity；Studies have shown that immunotherapy… 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?
Fruquintinib+PD-1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
Apr 2023to Mar 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 old, regardless of gender, volunteer to participate in the trial and sign informed consent；
  • Advanced gastric adenocarcinoma confirmed by pathology (including gastroesophageal junction adenocarcinoma) with extragastric measurable lesions (RECIST 1.1 criteria)；
  • Advanced HER-2-negative gastric cancer patients who received first-line PD-1 inhibitors (nivolumab/sindilizumab/tirelizumab) combined with standard chemotherapy and were assessed as non-PD according to RECIST 1.1 criteria；Chemotherapy regimen: SOX/FOLFOX/CAPEOX or fluorouracil combined with purple shirt；Patients receiving single-agent chemotherapy were allowed to enroll；Chemotherapy regimens are used for 4-8 cycles；
  • ECOG score: 0-1；
  • Expect to survive for at least 3 months；
  • Major organ function within 7 days before treatment meets the following criteria: (1) hemoglobin (HB) ≥90 g/L； (2) Absolute neutrophil ANC ≥1.5×109/L； (3) Platelet (PLT) ≥100×109/L；
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  • Biochemical tests should meet the following criteria: (1) Total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN), or ≤2.5 times the upper limit of normal value (ULN) in the case of liver metastasis (2) alanine aminotransferase (ALT) and aspartate aminotransferase AST≤2.5 ×ULN, if accompanied by liver metastasis, ALT and AST≤5×ULN(3) Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr)≥60ml/min；
  • Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ the lower limit of normal (50%)；
  • Patients of childbearing age (including female and female partners of male patients) must take effective birth control measures
  • he subjects volunteered to participate in this study and signed the ICF；
  • Good compliance is expected, and the efficacy and adverse reactions can be followed up according to the protocol requirements.

Who cannot join

  • Previous use of antiangiogenic drugs, such as bevacizumab, apatinib, anlotinib, lenvatinib and other antiangiogenic drugs
  • Previous treatment with more than one immune checkpoint inhibitor；
  • Patients who had previously interrupted treatment due to immune-related toxicity during immunotherapy；
  • Patients with severe history of allergy or allergic constitution；
  • Pregnant or lactating women；
  • Patients who have participated in other clinical trials and have not terminated the trial；
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  • Patients with a definite propensity for gastrointestinal bleeding. Including the following conditions: ① local active ulcer lesions, and stool occult blood 2+ or abovePatients with fecal occult blood 2+ allowed to retest fecal occult blood and determined by the investigator to have a clear benefit could be enrolled) ② Patients with melena and hematemesis within 3 months； ③ Gastroscopy is required for patients with fecal occult blood 1+ and primary gastric tumor that has not been surgically resected, such as ulcerated gastric cancer, and major gastrointestinal bleeding may occur according to the main investigator of the center；
  • Patients with any severe and/or uncontrolled disease, including: (1) patients with poorly controlled blood pressure (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg)； (2) Patients with grade I or higher myocardial ischemia or infarction, arrhythmias (including QTc ≥ 480ms), or congestive heart failure grade 2 (New York Heart Association (NYHA) classification)； (3) Active or uncontrolled severe infection (≥CTC AE grade 2 infection)； (4) Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis need antiviral therapy； (5) Renal failure requiring hemodialysis or peritoneal dialysis； (6) Have a history of immunodeficiency, including being HIV positive or suffering from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation； (7) Two consecutive routine urine tests indicated urinary protein ≥++, and confirmed 24-hour urinary protein quantity > 1.0 g； (8) suffer from mental illness, including epilepsy, dementia, severe depression, mania, etc
  • Receiving major surgical treatment, open biopsy or obvious traumatic injury within 28 days before grouping (body-body clinical evaluation)
  • Any history of active autoimmune disease or autoimmune disease, including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, pituitary inflammation, vasculitis, systemic lupus erythematosus, etc.
  • Patients whose imaging showed that the tumor had invaded the periphery of important blood vessels or who were judged by the investigator to be highly likely to invade important blood vessels during the subsequent study and cause fatal massive bleeding；
  • Patients with any evidence of bleeding constitution or history, regardless of severity；Patients who had any bleeding or bleeding events ≥CTCAE grade 3 in the 4 weeks before enrollment had unhealed wounds, ulcers, or fractures；
  • 6 months have experienced an arteriovenous thrombotic event, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism；
  • Patients with brain metastases associated with symptoms or symptom control for less than 2 months；
  • Persons with a history of psychotropic drug abuse and inability to abstain or mental disorders；
  • Subjects with dysphagia or known drug absorption disorders；
  • Other conditions deemed inappropriate for inclusion by the investigator。

Trial locations and contacts

1 site in 1 country.

wu jun contact

13057144311

wujun68@sina.com

China1 site, 1 recruiting

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213004

    wu jun, 13057144311, wujun68@sina.com

    Recruiting

Other trials in China

About this study

Maintenance therapy is very important in advanced HER-2 negative gastric cancer, and immune monotherapy has no obvious benefit in the first-line maintenance treatment of advanced gastric cancer； Fruquintinib is a potent small-molecule VEGFR inhibitor with high kinase selectivity；Studies have shown that immunotherapy combined with antiangiogenic agents is promising for synergistic antitumor effects； The aim of this study was to observe and evaluate the efficacy and safety of Fruquintinib combined with PD-1 inhibitor in the first-line maintenance treatment of advanced HER-2 negative gastric cancer.

Conditions
Gastric Cancer
Being tested
Fruquintinib+PD-1
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Fruquintinib+PD-1Drug

    This is a one-arm, prospective, exploratory clinical study, including patients with advanced HER-2-negative gastric cancer (including gastroesophageal junction adenocarcinoma) who received first-line immunization combined with standard chemotherapy (RECIST 1.1 criteria) and were treated with fruquintinib（4mg orally, once daily for 3 wks on/1 wk off ）combined with PD-1 antibody. Until the investigator assesses loss of clinical benefit, unacceptable toxicity, decision by the investigator or subject to withdraw treatment, or death, whichever comes first.

    PD-1: Nivolumab(360mg IV d1, Q3W）；Sintilimab(200mg IV d1, Q3W）；Tislelizumab(200mg IV d1, Q3W） can be selected;

Study groups in NCT05721651
Study groupRoleWhat they receive
ExperimentalExperimentalFruquintinib+PD-1
Receives: Drug: Fruquintinib+PD-1

What is being measured

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

  1. Progression free survival (PFS)

    Tumor assessment will be performed using radiography method every 8 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1

    Measured: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year

Secondary outcomes (4)

  1. Overall survival (OS)

    Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1

    Measured: from randomization until death due to any cause, assessed up to 3 year

  2. Objective response rate (ORR)

    Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1

    Measured: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year

  3. Disease control rate (DCR)

    Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1

    Measured: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year

  4. Safety and tolerance evaluated by incidence, severity and outcomes of AEs

    Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 5.0

    Measured: from first dose to 30 days post the last dose

Timeline

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

  1. First posted10 Feb 2023
  2. Study startApr 2023 (estimated)
  3. Primary completionMar 2025 (estimated)
  4. Study completionMar 2026 (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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05721651
Sponsor's protocol ID
HMPL-013-E2-GC-102
Status last verified
Apr 2023
First submitted
1 Feb 2023
Last updated
12 Apr 2023
Results posted
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 Fruquintinib+PD-1 in people with Gastric Cancer, run by Wu Jun 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 11 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: status not confirmed, as of the sponsor's last update on 12 Apr 2023. 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?

Results are not available in the source record.

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

Contact wu jun (13057144311, wujun68@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) (time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year). 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 NCT05721651.

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 12 Apr 2023.

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