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HER2-positive Gastric CancerPhase 2NCT06730373

First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)

A Phase 2 study testing Disitamab Vedotin, Sintilimab and S-1 in people with HER2-positive Gastric Cancer and Metastatic Gastric Cancer, run by Qilu Hospital of Shandong University at 20 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a Phase II, randomized, multicenter, open-label clinical trial designed to compare Disitamab Vedotin plus Sintilimab and S-1 with Trastuzumab plus chemotherapy ± Sintilimab for first-line treatment of HER2-Positive advanced gastric or gastroesophageal junction adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Disitamab Vedotin, Sintilimab and S-1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
20 sitesChina
Study dates
17 Oct 2024to 31 Dec 2027
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

  • Aged18-80 years, gender is not limited;
  • Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;
  • HER2-Positive (IHC3+or IHC2+/FISH+) ;
  • 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;
  • Adequate organ function;
  • The life expectancy is at least 3 months;

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;
  • 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;
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  • 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;

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lian Liu, MD contact

0531-82169851

tounao@126.com

Song Li, MD contact

0531-82169851

20 sites in 1 country

China20 sites, 20 recruiting

  • Binzhou Medical University Hospital

    Binzhou, Shandong

    Feng Wang

    Not yet recruiting

  • Shengli Oilfield Central Hospital

    Dongying, Shandong

    Tingting Zhang, MD, 18766757077, ztt850426@163.com

    Recruiting

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong, 250012

    Lei Cong, MD, 15168889208, wdconglei@163.com

    Lei Cong, MD

    Recruiting

  • Shandong Provincial Third Hospital

    Jinan, Shandong, 250012

    Kainan Li, Doctor, 15053125301, lkn_bean@163.com

    Recruiting

  • Shandong Univerisity Qilu Hospital

    Jinan, Shandong, 250012

    Lian Liu, MD, PhD, 18560082903, lianliu@sdu.edu.cn

    Recruiting

  • Jinan Third People's Hospital

    Jinan, Shandong

    Zupeng Luan

    Recruiting

  • Affiliated Hospital of Jining Medical College

    Jining, Shandong

    Junye Wang, MD

    Recruiting

  • Liaocheng People's Hospital

    Liaocheng, Shandong

    Baozhong Wang

    Recruiting

  • Linyi Cancer Hospital

    Linyi, Shandong

    Zhen Li

    Recruiting

  • Qilu Hospital of Shandong University(Qingdao)

    Qingdao, Shandong, 250063

    Fangli Cao, MD, 18561811170, qdsunying@foxmail.com

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

    Zimin Liu

    Not yet recruiting

  • Taian City Central Hospital

    Taian, Shandong

    Li Meng, MD

    Not yet recruiting

  • The Second Affiliated Hospital of Shandong First Medical University

    Taian, Shandong

    Haiyan Liu, MD, 13001770627, Fylhy1998@163.com

    Recruiting

  • Tengzhou Central People's Hospital

    Tengzhou, Shandong, 277599

    Ling Li, MD, 13863260929, lilingtz@163.com

    Recruiting

  • Weifang Hospital of Traditional Chinese Medicine

    Weifang, Shandong

    Zhonghai Du

    Not yet recruiting

  • Yantai Yuhuangding Hospital

    Yantai, Shandong

    Aina Liu, nana4312@sina.com

    Recruiting

  • Yantaishan Hospital

    Yantai, Shandong

    Dongmei Zhou, MD, 13953590373, zhoudongmei68@163.com

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Yongxu Jia, MD, +86 15237128281, jiayongxu111@126.com

    Yanru Qin, MD, yanruqin@163.com

    Recruiting

  • Zibo Central Hospital

    Zibo, Shandong

    Yi Zhai, MD, 18678186991, zhai-yi@21cn.com

    Recruiting

  • Zibo First People's Hospital

    Zibo, Shandong

    Fei Ding

    Recruiting

Other trials in China

About this study

Official title: A Phase II, Open-Label, Multicenter Trial Comparing Disitamab Vedotin Plus Sintilimab and S-1 With Trastuzumab Plus Chemotherapy ± Sintilimab for First-Line Treatment of HER2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (RCTS2)

This is a Phase II, randomized, multicenter, open-label clinical trial designed to compare Disitamab Vedotin plus Sintilimab and S-1 with Trastuzumab plus chemotherapy ± Sintilimab for first-line treatment of HER2-Positive advanced gastric or gastroesophageal junction adenocarcinoma.

Being tested
Disitamab Vedotin, Sintilimab, S-1, Trastuzumab, Oxaliplatin
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Disitamab VedotinDrug

    2.5 mg/kg IV every 3 weeks

  • SintilimabDrug

    200 mg IV every 3 weeks

  • S-1Drug

    40-60 mg BID for 14 days, every 3 weeks

  • TrastuzumabDrug

    First load dose is 8.0mg/kg , then 6.0 mg/kg IV every 3 weeks

  • OxaliplatinDrug

    130 mg/m2 Q3W

  • CapecitabineDrug

    1000 mg/m² Q3W

  • 5-FUDrug

    800 mg/m²

  • CisplatinDrug

    80 mg/m²

Study groups in NCT06730373
Study groupRoleWhat they receive
Disitamab Vedotin+Sintilimab+S-1ExperimentalNot described
Receives: Drug: Disitamab Vedotin; Drug: Sintilimab; Drug: S-1
Trastuzumab+Chemotherapy（XELOX/FP/XP) ± SintilimabActive comparatorNot described
Receives: Drug: Sintilimab; Drug: Trastuzumab; Drug: Oxaliplatin; Drug: Capecitabine; Drug: 5-FU; Drug: Cisplatin

What is being measured

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

  1. Objective remission 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 (5)

  1. Progression-free survival (PFS)

    Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.

    Measured: 12 months after the last subject participating in

  2. Overall survival (OS)

    Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.

    Measured: 12 months after the last subject participating in

  3. Duration of relief (DOR)

    DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death

    Measured: 12 months after the last subject participating in

  4. Disease control rate (DCR)

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

    Measured: 6 months after the last subject participating in

  5. Safety(adverse event)

    to evaluate safety including adverse event rate and adverse event grade.

    Measured: Up to approximately 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 posted12 Dec 2024
  2. Study start17 Oct 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06730373
Sponsor's protocol ID
RCTS2
Status last verified
Sep 2026
First submitted
4 Dec 2024
Last updated
15 Sep 2026
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 Disitamab Vedotin, Sintilimab and S-1 in people with HER2-positive Gastric Cancer and Metastatic Gastric Cancer, run by Qilu Hospital of Shandong University at 20 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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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?

Contact Lian Liu, MD (0531-82169851, tounao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective remission 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 NCT06730373.

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 15 Sep 2026.

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