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HER2-positive Gastric CancerPhase 2RCTSNCT05586061

First-line Treatment with RC48 Plus Tislelizumab and S-1(RCTS) in Advanced Gastric Cancer

A Phase 2 study testing Disitamab vedotin, Tislelizumab and S1 in people with HER2-positive Gastric Cancer, run by Qilu Hospital of Shandong University at 7 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a prospective, single arm, multicenter phase II study aimed at evaluating the efficacy and safety of Disitamab Vedotin in Combination With Tirelizumab and S-1 as first-line treatment for patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma. 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?
Disitamab vedotin, Tislelizumab and S1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
7 sitesChina
Study dates
10 Feb 2023to 31 Dec 2025
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

  • Aged18-75 years, gender is not limited;
  • Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;
  • HER2 was detected as 2+or 3+ by immunohistochemistry（IHC） ;
  • Has at least 1 measurable lesion as determined by RECIST 1.1;
  • There is no systematic treatment in the past, or the patient has received neoadjuvant/adjuvant chemotherapy, but the disease progresses or relapses more than 6 months after the end of treatment;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
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  • Adequate organ function:
  • Bone marrow function: i. Hemoglobin count (HGB)≥80g/L; ii. Neutrophil count (NE)≥1.5×109/L; iii. White blood cell count (WBC)≥3.5×109/L; iv. Platelet count (PLT)≥100×109/L；
  • Liver function: i. Serum total bilirubin (TBIL)≤1.5×ULN; ii. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP)≤3×ULN, patients with liver metastasis≤5×ULN;
  • Kidney function: Blood creatinine (Cr) ≤1.5×ULN or Cockcroft Gault formula ≥ 60 mL/min;
  • Cardiac function: New York Heart Association (NYHA) classification<Grade 3; Left ventricular ejection fraction≥50%;
  • The life expectancy is at least 3 months;
  • Female of childbearing age must have taken reliable contraceptive measures or conducted a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the trial period and 8 weeks after the last administration of the test drug; For male, they must agree to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the trial drug;
  • Willing to join the study and signed an informed consent form (ICF) with good compliance and cooperation in follow-up.

Who cannot join

  • Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;
  • Cardiovascular and cerebrovascular events that are not well controlled, such as:
  • NYHA grade 2 or above heart failure;
  • Unstable angina pectoris;
  • Myocardial infarction occurred within 1 year;
  • Supraventricular or ventricular arrhythmia with clinical significance needs treatment or intervention;
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  • Cerebral hemorrhage and cerebral infarction (except for lacunar cerebral infarction without symptoms and without treatment);
  • Serious cardiovascular and cerebrovascular events occurred within 12 months;
  • Uncontrolled hypertension, i.e. systolic blood pressure>140 mmHg or diastolic blood pressure>90 mmHg after single drug treatment;
  • Patients with history of arterial thrombosis or deep vein thrombosis within 6 months before recruitment, or with evidence of bleeding tendency or medical history within 2 months before recruitment, regardless of the severity;
  • Stroke event or transient ischemic attack occurred within 12 months before recruitment;
  • Has received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2 weeks.
  • Have a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.);
  • Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases;
  • Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection.Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment;
  • Brain metastasis or leptomeningeal metastasis;
  • Clinically significant pleural effusion, pericardial effusion or ascites should be drained for many times within 2 weeks before the first administration of the trial drug;
  • Has a second clinically detectable primary malignant tumor at the time of recruitment, or there were other malignant tumors in the past 5 years (except for fully treated skin basal cell carcinoma or cervical carcinoma in situ);
  • Any major surgery was performed ≤ 28 days before the first trial drug administration;
  • History of allogeneic stem cell transplantation or organ transplantation;
  • Duodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases at present; or other conditions that may cause gastrointestinal bleeding or perforation judged by the researchers; or history of intestinal perforation or fistula, but has not recovered after surgical treatment;
  • Live vaccine was inoculated within 4 weeks (inclusive) before the first administration of the trial drug, not including seasonal influenza vaccines but intranasal vaccine.
  • Has other factors that may lead to the forced termination of this trial according to the judgment of the investigator, such as other serious diseases (including psychological and mental diseases) requiring combined treatment, serious laboratory examination abnormalities, and family or social factors, which may affect the safety of the subject, or the collection of data and samples;
  • Participating in other therapeutic clinical studies or using research instruments within 4 weeks before the first administration;
  • Others conditions do not meet the inclusion according to the judgment of the investigator.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Central Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong, 250012

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • Shandong Provincial Hospital Affiliated to Shandong First Medical Universiry

    Jinan, Shandong, 250012

  • The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)

    Jinan, Shandong, 250012

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

  • Qingdao Municipal Hospital (Group)

    Qingdao, Shandong, 266011

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264000

Other trials in China

About this study

Official title: A Prospective, Multicenter, Phase II Clinical Study of First-line Treatment for HER2 (human Epidermal Growth Factor Receptor 2) Positive Advanced Gastric Cancer with Disitamab Vedotin in Combination with Tirelizumab and S-1

This is a prospective, single arm, multicenter phase II study aimed at evaluating the efficacy and safety of Disitamab Vedotin in Combination With Tirelizumab and S-1 as first-line treatment for patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma.

Being tested
Disitamab vedotin, Tislelizumab, S1

What participants receive

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

  • Disitamab vedotinDrug

    Also called RC48

    Disitamab Vedotin: 2.5mg/kg, d1, ivdrip, (every 3 weeks) Q3W

  • TislelizumabDrug

    Also called BGB-A317

    Tislelizumab: 200mg, d1, ivdrip, (every 3 weeks) Q3W

  • S1Drug

    S-1: 40-60mg (according to patients' body surface area), po, bid, d1-14, discontinued for 7 days.

Study groups in NCT05586061
Study groupRoleWhat they receive
RC48 Plus Tislelizumab and S-1(RCTS)ExperimentalDisitamab Vedotin: 2.5mg/kg, ivdrip, d1, (every 3 weeks) Q3W； Tislelizumab: 200mg, ivdrip, d1, (every 3 weeks) Q3W； S-1: 40-60mg(according to patients' body surface area), po, bid, d1-14 and discontinued for 7 days in each cycle; until progressive disease (PD) or intolerable toxicity
Receives: Drug: Disitamab vedotin; Drug: Tislelizumab; Drug: S1

What is being measured

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

  1. objective response rate (ORR)

    The proportion of subjects with complete response (CR) and partial response (PR) in total subjects

    Measured: 6 months after the last subject participating in

Secondary outcomes (4)

  1. progression-free survival (PFS)

    Progression-free survival (PFS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first

    Measured: 12 months after the last subject participating in

  2. overall survival (OS)

    OS is defined as the time from the starting date of study drug to the date of death due to any cause.

    Measured: 12 months after the last subject participating in

  3. disease control rate (DCR)

    The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD)in total subjects

    Measured: 12 months after the last subject participating in

  4. duration of response (DOR)

    DOR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.

    Measured: 12 months after the last subject participating in

Timeline

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

  1. First posted19 Oct 2022
  2. Study start10 Feb 2023
  3. Primary completion29 Dec 2024
  4. Study completion31 Dec 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05586061
Sponsor's protocol ID
RCTS
Acronym
RCTS
Status last verified
Feb 2025
First submitted
16 Oct 2022
Last updated
7 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Disitamab vedotin, Tislelizumab and S1 in people with HER2-positive Gastric Cancer, run by Qilu Hospital of Shandong University at 7 sites 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 14 inclusion and 25 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: under way, not looking for participants, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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?

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?

objective response rate (ORR) (time frame: 6 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 NCT05586061.

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 7 Feb 2025.

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