First-line Treatment with RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)
- Registration Number
- NCT06730373
- Lead Sponsor
- Qilu Hospital of Shandong University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 110
- Aged18-75 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;
- 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;
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Disitamab Vedotin+Sintilimab+S-1 Disitamab Vedotin - Disitamab Vedotin+Sintilimab+S-1 Sintilimab - Trastuzumab+Chemotherapy（XELOX/FP/XP) ± Sintilimab Trastuzumab - Trastuzumab+Chemotherapy（XELOX/FP/XP) ± Sintilimab Oxaliplatin - Trastuzumab+Chemotherapy（XELOX/FP/XP) ± Sintilimab Capecitabine - Trastuzumab+Chemotherapy（XELOX/FP/XP) ± Sintilimab 5-FU - Trastuzumab+Chemotherapy（XELOX/FP/XP) ± Sintilimab Cisplatin - Disitamab Vedotin+Sintilimab+S-1 S-1 - Trastuzumab+Chemotherapy（XELOX/FP/XP) ± Sintilimab Sintilimab -
- Primary Outcome Measures
Name Time Method Objective remission rate (ORR) 6 months after the last subject participating in The proportion of subjects with complete response (CR) and partial response (PR) in total subjects
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) 12 months after the last subject participating in 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.
Overall survival (OS) 12 months after the last subject participating in Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.
Duration of relief (DOR) 12 months after the last subject participating in DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
Disease control rate (DCR) 6 months after the last subject participating in The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD)in total subjects
Safety(adverse event) Up to approximately 2 years to evaluate safety including adverse event rate and adverse event grade.
Trial Locations
- Locations (19)
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
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