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HER2-positive Gastric CancerPhase 2NCT06439550

Adjuvant Treatment With Serplulimab，Trastuzumab and SOX in the HER-2 Positive GC/GEJC

A Phase 2 study testing Serplulimab, Trastuzumab and Oxaliplatin + Tegafur in people with HER2-positive Gastric Cancer, run by The First Affiliated Hospital of Zhengzhou University.

Not yet recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

This is a prospective, single arm, multicenter phase II study to assess the effectiveness of Serplulimab，Trastuzumab and SOX in the adjuvant treatment of HER-2 Positive Gastric/Gastroesophageal Junction Carcinoma (GC/GEJC) 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?
Serplulimab, Trastuzumab and Oxaliplatin + Tegafur
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
No sites listed yet
Study dates
15 Jul 2024to 31 Dec 2026
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

  • Histologically confirmed gastric adenocarcinoma/esophagogastric junction adenocarcinoma, HER-3 + or HER-2 +, with Fish amplification;
  • Subjects must complete R0 resection before enrollment；If they received neoadjuvant therapy, it was required that the neoadjuvant therapy regimen should not contain anti-HER-2 targeted drugs;
  • Postoperative pathology: II-III;
  • Age 18-75 years old;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
  • Blood routine and biochemistry within 7 days before enrollment : a. Hemoglobin ≥90g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelets ≥100×109/L (no blood transfusion within 14 days before treatment, no granulocyte colony-stimulating factor, no correction with other drugs); b. ALT and AST≤2.5 times the normal upper limit (ULN); ALP≤2.5 times ULN; c. Serum total bilirubin <1.5 ULN (Gilbert syndrome patients with total bilirubin <3 ULN can be enrolled); d. Serum creatinine <1.5 ULN or estimated glomerular filtration rate ≥60ml/min/1.73m2; e. Serum albumin ≥30g/L; f. International Normalized Ratio (INR) or prothrombin time (PT) ≤1.5 times ULN, unless the patient is receiving anticoagulant therapy and the PT value is within the intended treatment range of the anticoagulant; g. Activated partial thromboplastin time (APTT) ≤1.5 times ULN.
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  • No serious concomitant diseases that make the survival time less than 5 years;
  • Voluntary and able to adhere to the program during the study;
  • Provide written informed consent form before entering the study, and the subjects has understood that he can withdraw from the study at any time during the study without any loss.

Who cannot join

  • A history of any other malignancy in the past 5 years (except carcinoma in situ or basal cell carcinoma of the skin or squamous cell carcinoma of the skin)；Patients with small gastric stromal tumors and other tumors may be excluded if the researcher determines that other tumors will not affect the patient's life in the short term；
  • Participated in clinical trials of other drugs within four weeks;
  • Have any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; subjects has vitiligo; asthma that has completely relieved in childhood and does not require any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included)
  • Requires systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration to treat a current condition.
  • Any active malignant tumour within 2 years, excluding the specific cancer being studied in this trial and the locally recurrent cancer that has been cured (such as basal cell or squamous cell skin cancer that has been removed, superficial bladder cancer cancer, cervical or breast cancer in situ);
  • Subjects with central nervous system metastasis or a history of central nervous system metastasis. With clinically suspected CNS metastasis, CT or MRI must be performed within 28 days before starting treatment to rule out CNS metastasis；
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  • With unstable angina pectoris; Newly diagnosed angina pectoris within 3 months prior to screening or myocardial infarction events occurred within 6 months prior to screening; Arrhythmias (including QTcF: ≥ 450 ms for males and ≥ 470 ms for females) require long-term use of antiarrhythmic drugs and a New York Heart Association grade of ≥ II cardiac dysfunction;
  • Or urinary protein qualitative ≥2+, 24 hours urinary protein > 1g
  • For female subjects: should be surgically sterilized, postmenopausal, or consent to use a medically approved contraceptive during the study treatment period and for 6 months after the end of the study treatment period; Serum or urine pregnancy tests must be negative within 7 days before enrollment and must be non-lactating. Male subjects: patients who should be surgically sterilized or who have consented to use a medically approved contraceptive method during the study treatment period and for 6 months after the end of the study treatment period;
  • Liver transplantation patients；
  • With infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other subjects require the use of corticosteroids;
  • Have a history of chronic autoimmune diseases, such as systemic lupus erythematosus;
  • Have a history of inflammatory bowel diseases such as ulcerative colitis and Crohn's disease, and a history of chronic diarrhea diseases such as irritable bowel syndrome；
  • Have a history of sarcoidosis or tuberculosis；
  • With active HBV, HCV，and HIV infection；
  • Subjects with a history of psychotropic substance abuse and are unable to abstain or have mental disorders; 17) Thoracic or abdominal effusion with clinical symptoms that require clinical intervention; 18) A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 19) According to the judgment of the researcher,there is a serious concomitant disease that endangers the patient's safety or interferes with the patient's completion of the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Feng Wang contact

13938244776

fengw010@163.com

About this study

Official title: Adjuvant Treatment With Serplulimab，Trastuzumab and SOX in the of HER-2 Positive Gastric/Gastroesophageal Junction Carcinoma (GC/GEJC)

This is a prospective, single arm, multicenter phase II study to assess the effectiveness of Serplulimab，Trastuzumab and SOX in the adjuvant treatment of HER-2 Positive Gastric/Gastroesophageal Junction Carcinoma (GC/GEJC)

Being tested
Serplulimab, Trastuzumab, Oxaliplatin + Tegafur

What participants receive

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

  • SerplulimabDrug

    300mg, q3w

  • TrastuzumabDrug

    First dose 8mg/kg, maintenance 6mg/kg, q3w

  • Oxaliplatin + TegafurDrug

    Also called SOX

    oxaliplatin (130mg/m2, q3w) + Tegafur (40mg/m2, bid d1-d14, q3w).

Study groups in NCT06439550
Study groupRoleWhat they receive
Serplulimab，Trastuzumab and SOXExperimentalWithin 4 weeks after surgery, patients will be enrolled in the study and started on Serplulimab (300mg, q3w) + Trastuzumab (First dose 8mg/kg, maintenance 6mg/kg, q3w) + oxaliplatin (130mg/m2, q3w) + Tegafur (40mg/m2, bid d1-d14, q3w). Among them, oxaliplatin + Teggio can be used for 4-6 cycles according to the patient's tolerance, and Serplulimab + trastuzumab can be continued until 12 months or tumor recurrence or metastasis
Receives: Drug: Serplulimab; Drug: Trastuzumab; Drug: Oxaliplatin + Tegafur

What is being measured

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

  1. Disease progression free survival （DFS）

    Objective response rate according to RECIST 1.1

    Measured: 24 months after the last subject participating in

Secondary outcomes (3)

  1. Overall survival (OS）

    Overall survival

    Measured: 24 months after the last subject participating in

  2. Recurrence rate

    Objective response rate according to RECIST 1.1

    Measured: 24 months after the last subject participating in

  3. 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: through study completion, an average of 1 year

Timeline

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

  1. First posted3 Jun 2024
  2. Study start15 Jul 2024 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 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
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06439550
Sponsor's protocol ID
HLX10IIT123
Status last verified
Nov 2023
First submitted
28 May 2024
Last updated
3 Jun 2024
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 Serplulimab, Trastuzumab and Oxaliplatin + Tegafur in people with HER2-positive Gastric Cancer, run by The First Affiliated Hospital of Zhengzhou 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 9 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 3 Jun 2024. 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?

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 Feng Wang (13938244776, fengw010@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease progression free survival （DFS） (time frame: 24 months after the last subject participating in). 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 NCT06439550.

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 3 Jun 2024.

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