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Metastatic Gastric CancerPhase 1/2NCT05024812

Fruquintinib Combined With Toripalimab and SOX Regimen in the First-line Treatment of Advanced Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

A Phase 1/2 study testing fruquintinib＋toripalimab + SOX in people with Metastatic Gastric Cancer, run by The First Affiliated Hospital of Zhengzhou University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a prospective, open-label, multicenter, single arm phase Ⅰb/Ⅱ clinical study aims to explore the efficacy and safety of fruquintinib combined with toripalimab and SOX regimen in the first-line treatment of unresectable advanced metastatic gastric or gastroesophageal junction adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Gastric Cancer
What is being tested?
fruquintinib＋toripalimab + SOX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteChina
Study dates
1 Jun 2022to Feb 2025
Phase
Phase 1/2
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

  • Pathologically determined unresectable advanced gastric or gastroesophageal junction adenocarcinoma;
  • 18-75 years old (including 18 and 75 years old);
  • No previous anti-tumor treatment for metastatic diseases;
  • HER2 negative;
  • Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;
  • Life expectancy ≥ 3 months;
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  • At least one measurable lesion according to RECIST version 1.1;
  • Adequate organ and bone marrow functions:
  • Absolute neutrophil count≥1.5x10^9/L; Platelet count≥100x10^9/L; Hemoglobin≥9g/dL; Serum bilirubin≤1.5x the upper limit of normal(ULN); Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)≤1.5x ULN; Serum creatinine≤1.5x ULN; Endogenous creatinine clearance rate ≥ 50ml / min;
  • Women of childbearing age need to take effective contraceptive measures.

Who cannot join

  • Previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors or previous use of immune checkpoint inhibitors;
  • Other malignant tumors in the past 5 years, except for skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;
  • There was central nervous system (CNS) metastasis or previous brain metastasis before enrollment;
  • Patients with autoimmune diseases or history of autoimmune diseases within 4 weeks before enrollment;
  • Previously received allogeneic bone marrow transplantation or organ transplantation;
  • Uncontrolled malignant ascites;
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  • Participated in other unapproved or unlisted drug clinical trials in China within 4 weeks before enrollment, and received corresponding experimental drug treatment;
  • Cardiovascular disease, including unstable angina or myocardial infarction, occurred within 6 months before the start of study treatment;
  • Subjects allergic to the study drug or any of its adjuvants;
  • International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN；
  • The researchers judged clinically significant electrolyte abnormalities;
  • At present, the patient has hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg;
  • Patients currently have poorly controlled diabetes (fasting glucose level is greater than CTCAE grade 2 after regular treatment);
  • Patients with dysphagia, active peptic ulcer, intestinal obstruction, active gastrointestinal bleeding, peptic perforation, malabsorption syndrome or uncontrolled intestinal inflammatory diseases;
  • Any disease or state affecting drug absorption before enrollment, or the patient cannot take oral medication;
  • Patients with obvious evidence of bleeding tendency or medical history within 3 months before enrollment, hemoptysis or thromboembolism within 12 months;
  • Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment;
  • Ventricular arrhythmia requiring drug treatment;
  • Congestive heart failure ≤New York Heart Association (NYHA) class 2;
  • LVEF < 50%;
  • Active or uncontrolled severe infection ≥ grade 2 according to National Cancer Institute Common Toxicity (NCI-CTC) criteria;
  • With positive urine protein and 24-hour urinary protein content>1g;
  • Known human immunodeficiency virus (HIV) infection; known history of clinically significant liver disease, including viral hepatitis;
  • Pregnant (positive pregnancy test before medication) or lactating women;
  • Complications require long-term immunosuppressive treatment, or systemic or local use of immunosuppressive corticosteroids (> 10mg / day prednisone or other therapeutic hormones);
  • By judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.

Trial locations and contacts

1 site in 1 country.

Feng Wang, M.D. contact

860013938244776

fengw010@163.com

Qingxia Fan, M.D. contact

China1 site, 1 recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Feng Wang, doctor

    Qingxia Fan, doctor

    Recruiting

Other trials in China

About this study

Official title: An Open Label, Single Arm, Multicenter Phase Ⅰb/Ⅱ Clinical Study of Fruquintinib Combined With Toripalimab and SOX Regimen in the First-line Treatment of Advanced Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

This is a prospective, open-label, multicenter, single arm phase Ⅰb/Ⅱ clinical study aims to explore the efficacy and safety of fruquintinib combined with toripalimab and SOX regimen in the first-line treatment of unresectable advanced metastatic gastric or gastroesophageal junction adenocarcinoma.

Read the detailed description

At present, the first-line standard treatment of metastatic gastric cancer is still doublet or triplet chemotherapy of fluorouracil combined with platinum or paclitaxel. In recent years, immune checkpoint inhibitors (ICIs) have emerged in advanced gastric cancer with their unique mechanism of action. PD-1 monoclonal antibody has been explored in multiple combination schemes in the first-line treatment of advanced gastric cancer. This study aims to explore the efficacy and safety of an antiangiogenetic TKI, fruquintinib combined with an ICI, toripalimab and the standard doublet SOX regimen in the first-line treatment of unresectable advanced metastatic gastric or gastroesophageal junction adenocarcinoma.

Being tested
fruquintinib＋toripalimab + SOX
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＋toripalimab + SOXDrug

    phase Ib: fruquintinib (dose finding): L1: 3 mg/d，L2: 4 mg/d，L3: 5 mg/d, qd po, D1-14, Q3W toripalimab: 240mg, I.V., D1, Q3W; S-1: 40-60mg bid, D1-14, Q3W; Oxaliplatin: 130mg/m^2, ivgtt 2h, D1,Q3W. phase II: fruquintinib: RP2D toripalimab: 240mg, I.V., D1, Q3W; S-1: 40-60mg bid, D1-14, Q3W; Oxaliplatin: 130mg/m^2, ivgtt 2h, D1,Q3W.

Study groups in NCT05024812
Study groupRoleWhat they receive
ExperimentalExperimentalfruquintinib + toripalimab + SOX
Receives: Drug: fruquintinib＋toripalimab + SOX

What is being measured

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

  1. DLTs

    DLTs are defined as grade 3 or higher adverse events that are related to fruquintinib during the first cycle of therapy.

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  2. RP2D

    Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  3. PFS

    PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.

    Measured: about 2 years

Secondary outcomes (5)

  1. OS

    The time from treatment initiation until death from any reason

    Measured: about 2 years

  2. ORR

    The proportion of patients with a confirmed complete response or partial response on two consecutive occasions≥4 weeks apart

    Measured: about 2 years

  3. DCR

    The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD)

    Measured: about 2 years

  4. DoR

    Duration of Response is defined as the time from the first documentation of response (PR or better) to the first documented disease progression evidence (according to RECIST 1.1) of the responders

    Measured: about 2 years

  5. adverse events (AEs) categorized by severity in accordance with the NCI CTC AE Version 5.0

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

    Measured: about 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 posted27 Aug 2021
  2. Study start1 Jun 2022
  3. Primary completionAug 2023 (estimated)
  4. Study completionFeb 2025 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05024812
Sponsor's protocol ID
HMPL-013-FLAG-G102
Status last verified
Aug 2022
First submitted
20 Aug 2021
Last updated
18 Aug 2022
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 1/2 study testing fruquintinib＋toripalimab + SOX in people with Metastatic Gastric Cancer, run by The First Affiliated Hospital of Zhengzhou 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 10 inclusion and 26 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 18 Aug 2022. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Feng Wang, M.D. (860013938244776, fengw010@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLTs (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 3 primary outcomes in all. 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 NCT05024812.

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 18 Aug 2022.

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