First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)
NCT ID: NCT06730373
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
110 participants
INTERVENTIONAL
2024-10-17
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Disitamab Vedotin+Sintilimab+S-1
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+Chemotherapy（XELOX/FP/XP) ± Sintilimab
Sintilimab
200 mg IV 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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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;
18 Years
75 Years
ALL
No
Sponsors
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Qilu Hospital of Shandong University
OTHER
Responsible Party
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Lian Liu, MD, PHD
Director
Principal Investigators
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Lian Liu, MD
Role: STUDY_CHAIR
Qilu Hospital of Shandong University
Locations
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The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Binzhou Medical University Hospital
Binzhou, Shandong, China
Shengli Oilfield Central Hospital
Dongying, Shandong, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Shandong Provincial Third Hospital
Jinan, Shandong, China
Shandong Univerisity Qilu Hospital
Jinan, Shandong, China
Jinan Third People's Hospital
Jinan, Shandong, China
Affiliated Hospital of Jining Medical College
Jining, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
Qilu Hospital of Shandong University(Qingdao)
Qingdao, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Taian City Central Hospital
Taian, Shandong, China
The Second Affiliated Hospital of Shandong First Medical University
Taian, Shandong, China
Tengzhou Central People's Hospital
Tengzhou, Shandong, China
Weifang Hospital of Traditional Chinese Medicine
Weifang, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Yantaishan Hospital
Yantai, Shandong, China
Zibo Central Hospital
Zibo, Shandong, China
Zibo First People's Hospital
Zibo, Shandong, China
Countries
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Central Contacts
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Song Li, MD
Role: CONTACT
Phone: 0531-82169851
Facility Contacts
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Yongxu Jia, MD
Role: primary
Yanru Qin, MD
Role: backup
Feng Wang
Role: primary
Tingting Zhang, MD
Role: primary
Lei Cong, MD
Role: primary
Kainan Li, Doctor
Role: primary
Lian Liu, MD, PhD
Role: primary
Zupeng Luan
Role: primary
Junye Wang, MD
Role: primary
Baozhong Wang
Role: primary
Zhen Li
Role: primary
Fangli Cao, MD
Role: primary
Zimin Liu
Role: primary
Li Meng, MD
Role: primary
Haiyan Liu, MD
Role: primary
Ling Li, MD
Role: primary
Zhonghai Du
Role: primary
Aina Liu
Role: primary
Dongmei Zhou, MD
Role: primary
Yi Zhai, MD
Role: primary
Fei Ding
Role: primary
Other Identifiers
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RCTS2
Identifier Type: -
Identifier Source: org_study_id