HER2-positive Gastric CancerPhase 2NCT05311189
Study of HLX10, Trastuzumab and Chemotherapy in First-line Treatment of HER2-positive Recurrent/Metastatic Gastric Cancer
A Phase 2 study testing HLX10, Trastuzumab and Chemotherapy in people with HER2-positive Gastric Cancer, run by Shanghai Zhongshan Hospital.
Trial summary
Investigators assessed the effectiveness of HLX10, Trastuzumab and Chemotherapy in First-line Treatment of HER2-positive Recurrent/Metastatic Gastric Cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HER2-positive Gastric Cancer
- What is being tested?
- HLX10, Trastuzumab and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2022to 31 Dec 2024
- 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
- Histologically or cytologically proven metastatic or locally advanced HER2-positive gastric cancer
- Documented disease progression after receiving prior line of trastuzumab-containing chemotherapy for gastric cancer
- Able and willing to give written informed consent and has signed the informed consent form (ICF), prior to performance of any trial activities.
- Eligible male and female subjects aged ≥18 years.
- Has measurable disease as determined by RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
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- Has baseline left ventricular ejection fraction (LVEF) ≥ 55%.
- Adequate organ function as demonstrated by laboratory test results within 14 days prior to first dose of study treatment.
- Have urinary protein that is <2 on dipstick or routine urinalysis.
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to first dose of study treatment.
- Female subjects of childbearing potential and male subjects should be willing to use methods of birth control for the course of the study and up to 120 days after the last dose of study treatment.
Who cannot join
- Received prior anticancer treatment with targeted agents, chemotherapy, or radiotherapy within 14 days, with monoclonal antibodies within 28 days, has previously received treatment with ramucirumab, or has participated in another clinical trial within 14 days prior to start of study treatment.
- Has experienced any Grade 3-4 gastrointestinal bleeding within 3 months prior to treatment.
- Has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 3 months prior to treatment.
- Has history of severe thromboembolism, including deep vein thrombosis and pulmonary embolism within 6 months prior to treatment.
- Has an active or ongoing infection, symptomatic congestive heart failure, （6）uncontrolled angina pectoris, symptomatic or poorly controlled arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator.
- （7）Has ongoing or active psychiatric illness or social situation that would limit compliance with study requirements.
- （8）Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- （9）Has evidence of active, non-infectious pneumonitis. （10）Have an elective or a planned major surgery during the course of the trial or has undergone major surgery within 4 weeks prior to enrollment.
About this study
Investigators assessed the effectiveness of HLX10, Trastuzumab and Chemotherapy in First-line Treatment of HER2-positive Recurrent/Metastatic Gastric Cancer
- Conditions
- HER2-positive Gastric Cancer
- Being tested
- HLX10, Trastuzumab and Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX10, Trastuzumab and ChemotherapyDrug
HLX10 4.5mg/kg, IV, q3weeks, Day 1 trastuzumab 6mg/kg (8mg loading dose), IV, q3weeks, Day 1 S1 40mg/m2, PO, BID, Day 1-14 oxaliplatin 100mg/m2, IV, q3weeks, Day 1 docetaxel 40mg/m2, IV, q3weeks, Day 1
| Study group | Role | What they receive |
|---|---|---|
| HLX10, Trastuzumab and Chemotherapy | Experimental | HLX10, Trastuzumab and Chemotherapy in First-line Treatment of HER2-positive Recurrent/Metastatic Gastric Cancer Receives: Drug: HLX10, Trastuzumab and Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival in patients with HER2-positive gastric cancer receiving HLX10, trastuzumab, and chemotherapy combination treatment
Measured: 18 months after start of treatment
Secondary outcomes (3)
Overall survival
Overall survival
Measured: through study completion, an average of 2 years
Objective response rate according to RECIST 1.1
Objective response rate according to RECIST 1.1
Measured: through study completion, an average of 2 years
Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE
Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE
Measured: Throughout the overall study period as well as up to 3 months after the last dose study treatment for each subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start15 Apr 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Gastric CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tianshu Liu, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311189
- Sponsor's protocol ID
- HLX10GCIIT01
- Status last verified
- Mar 2022
- First submitted
- 23 Mar 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of HLX10, Trastuzumab and Chemotherapy in First-line Treatment of HER2-positive Recurrent/Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT05311189
- Acronym / sponsor ID
- HLX10GCIIT01
- Conditions
- HER2-positive Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 15 Apr 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators assessed the effectiveness of HLX10, Trastuzumab and Chemotherapy in First-line Treatment of HER2-positive Recurrent/Metastatic Gastric Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HLX10, Trastuzumab and Chemotherapy | Experimental | Drug: HLX10, Trastuzumab and ChemotherapyHLX10, Trastuzumab and Chemotherapy in First-line Treatment of HER2-positive Recurrent/Metastatic Gastric Cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically or cytologically proven metastatic or locally advanced HER2-positive gastric cancer
- Documented disease progression after receiving prior line of trastuzumab-containing chemotherapy for gastric cancer
- Able and willing to give written informed consent and has signed the informed consent form (ICF), prior to performance of any trial activities.
- Eligible male and female subjects aged ≥18 years.
- Has measurable disease as determined by RECIST 1.1.
Key exclusion criteria (8 listed)
- Received prior anticancer treatment with targeted agents, chemotherapy, or radiotherapy within 14 days, with monoclonal antibodies within 28 days, has previously received treatment with ramucirumab, or has participated in another clinical trial within 14 days prior to start of study treatment.
- Has experienced any Grade 3-4 gastrointestinal bleeding within 3 months prior to treatment.
- Has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 3 months prior to treatment.
- Has history of severe thromboembolism, including deep vein thrombosis and pulmonary embolism within 6 months prior to treatment.
- Has an active or ongoing infection, symptomatic congestive heart failure, （6）uncontrolled angina pectoris, symptomatic or poorly controlled arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLX10, Trastuzumab and ChemotherapyHLX10 4.5mg/kg, IV, q3weeks, Day 1 trastuzumab 6mg/kg (8mg loading dose), IV, q3weeks, Day 1 S1 40mg/m2, PO, BID, Day 1-14 oxaliplatin 100mg/m2, IV, q3weeks, Day 1 docetaxel 40mg/m2, IV, q3weeks, Day 1 | Drug | HLX10, Trastuzumab and Chemotherapy |
Primary outcome
Progression-free survival
Time frame: 18 months after start of treatment
Progression-free survival in patients with HER2-positive gastric cancer receiving HLX10, trastuzumab, and chemotherapy combination treatment
3 secondary outcomes
Overall survival
Time frame: through study completion, an average of 2 years
Objective response rate according to RECIST 1.1
Time frame: through study completion, an average of 2 years
Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE
Time frame: Throughout the overall study period as well as up to 3 months after the last dose study treatment for each subject
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HLX10, Trastuzumab and Chemotherapy in people with HER2-positive Gastric Cancer, run by Shanghai Zhongshan Hospital.
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 8 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 5 Apr 2022. 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 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?
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?
Progression-free survival (time frame: 18 months after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2022.