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Clinical Trials in China / NCT06730373
Recruiting Phase 2

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

NCT06730373 · tracked via the Priya Life Science China tracker
Sponsor
Qilu Hospital of Shandong University
Phase
Phase 2
Started
2024-10-17
Last updated
2026-09-15

Condition(s) studied

HER2-positive Gastric CancerMetastatic Gastric CancerUnresectable Gastric Carcinoma

Investigational drug(s) / intervention(s)

Disitamab VedotinSintilimabS-1TrastuzumabOxaliplatinCapecitabine5-FUCisplatin

Disitamab Vedotin: 2.5 mg/kg IV every 3 weeks

Sintilimab: 200 mg IV every 3 weeks

S-1: 40-60 mg BID for 14 days, every 3 weeks

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

Oxaliplatin: 130 mg/m2 Q3W

Capecitabine: 1000 mg/m² Q3W

5-FU: 800 mg/m²

Cisplatin: 80 mg/m²

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Aged18-80 years, gender is not limited; 2. Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis; 3. HER2-Positive (IHC3+or IHC2+/FISH+) ; 4. Has at least 1 measurable lesion as determined by RECIST 1.1; 5. 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; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 7. Adequate organ function; 8. The life expectancy is at least 3 months; Exclusion Criteria: 1. Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug; 2. Cardiovascular and cerebrovascular events that are not well controlled; 3. 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. 4. 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.); 5. 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; 6. 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; 7. Brain metastasis or leptomeningeal metastasis; 8. 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; 9. 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); 10. Any major surgery was performed ≤ 28 days before the first trial drug administration; 11. History of allogeneic stem cell transplantation or organ transplantation;

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan Recruiting
Binzhou Medical University Hospital Binzhou Shandong Not Yet Recruiting
Shengli Oilfield Central Hospital Dongying Shandong Recruiting
Shandong Provincial Hospital Affiliated to Shandong First Medical University Jinan Shandong Recruiting
Shandong Provincial Third Hospital Jinan Shandong Recruiting
Shandong Univerisity Qilu Hospital Jinan Shandong Recruiting
Jinan Third People's Hospital Jinan Shandong Recruiting
Affiliated Hospital of Jining Medical College Jining Shandong Recruiting
Liaocheng People's Hospital Liaocheng Shandong Recruiting
Linyi Cancer Hospital Linyi Shandong Recruiting
Qilu Hospital of Shandong University(Qingdao) Qingdao Shandong Recruiting
The Affiliated Hospital of Qingdao University Qingdao Shandong Not Yet Recruiting
Taian City Central Hospital Taian Shandong Not Yet Recruiting
The Second Affiliated Hospital of Shandong First Medical University Taian Shandong Recruiting
Tengzhou Central People's Hospital Tengzhou Shandong Recruiting
Weifang Hospital of Traditional Chinese Medicine Weifang Shandong Not Yet Recruiting
Yantai Yuhuangding Hospital Yantai Shandong Recruiting
Yantaishan Hospital Yantai Shandong Recruiting
Zibo Central Hospital Zibo Shandong Recruiting
Zibo First People's Hospital Zibo Shandong Recruiting

On this site

📄 Herceptin (trastuzumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06730373 on ClinicalTrials.gov ↗ ← All trials in China