Actively Recruiting
Second-line Treatment With Serplulimab, Lenvatinib, and Paclitaxel in Advanced Gastric Cancer After Prior Immunotherapy
Led by Qilu Hospital of Shandong University · Updated on 2025-01-07
59
Participants Needed
7
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single arm, multicenter phase II study to assess the effectiveness of Serplulimab, Lenvatinib and Paclitaxel in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma after first-line immunotherapy.
CONDITIONS
Official Title
Second-line Treatment With Serplulimab, Lenvatinib, and Paclitaxel in Advanced Gastric Cancer After Prior Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosed with metastatic or locally advanced gastric or gastroesophageal junction adenocarcinoma confirmed by histology or cytology
- PD-L1 positive (CPS ≥ 1) or achieved objective response to first-line PD-1/PD-L1 inhibitor therapy or had progression-free survival of 6 months or more after first-line PD-1/PD-L1 therapy
- Prior toxicities from chemotherapy, surgery, radiotherapy, or immunotherapy (except hair loss) have resolved to mild or less (CTCAE grade 1 or lower)
- Presence of measurable disease per RECIST 1.1 criteria
- Ability to provide tissue samples for PD-L1 testing, preferably recent tumor tissue before second-line therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function including: neutrophil count >1.5×10^9/L; hemoglobin >90 g/L; platelets >100×10^9/L; coagulation INR or PT ≤1.5× upper limit of normal; creatinine clearance ≥50 mL/min; total bilirubin ≤1.5× upper limit of normal; AST, ALT, and ALP ≤2.5× upper limit of normal; albumin >2.7 g/dL
- Urine protein ≤1+
- Life expectancy of at least 6 months as judged by investigator
- Able and willing to sign informed consent form
- Female participants must be surgically sterilized, postmenopausal, or use highly effective contraception during treatment and for 12 weeks after; male participants must be surgically sterilized or use effective contraception during treatment and for 6 months after
You will not qualify if you...
- Human epidermal growth factor receptor 2 (HER2) positive status
- Previous treatment with multi-target small molecule inhibitors such as lenvatinib or paclitaxel
- Systemic or local therapy for advanced disease within 14 days before enrollment
- Difficult-to-control hypertension with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥90 mmHg
- Brain metastases, cancerous meningitis, spinal cord compression, or brain/leptomeningeal disease found by imaging
- Refractory pleural effusion or ascites requiring drainage within 2 weeks before first treatment
- Other malignancies except cured cervical carcinoma in situ, non-melanoma skin cancer, or superficial bladder tumors (Ta, Tis, T1)
- Allergy to any study drug or its ingredients
- Chronic hepatitis B with DNA >500 IU/mL or active hepatitis C infection
- Active autoimmune disease or history of autoimmune disease, or history of organ or stem cell transplant
- Long-term heavy use of hormones or other immunomodulators
- Active infection
- Vaccination with live or attenuated vaccines within 30 days before first dose or planned during study, excluding COVID-19 vaccine
- Arterial or venous thrombotic events within 6 months
- Severe cardiovascular disease including myocardial ischemia or infarction grade II or higher, recent stent placement, poorly controlled arrhythmia, NYHA class III-IV heart failure, or left ventricular ejection fraction under 50%
- History of interstitial lung disease or uncontrolled systemic diseases
- Known HIV infection
- Major surgery under general anesthesia within 28 days before first dose
- Medical conditions or substance abuse that may affect treatment or study results
- Participation in other therapeutic clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Qilu hospital of Shandong univertisy
Jinan, Shandong, China, 250012
Actively Recruiting
2
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China, 250012
Actively Recruiting
3
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, Shandong, China, 250012
Actively Recruiting
4
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000
Actively Recruiting
5
Qingdao Municipal Hospital（Group）
Qingdao, Shandong, China, 266011
Actively Recruiting
6
Yantai Yuhuangding Hospital
Yantai, Shandong, China, 264000
Not Yet Recruiting
7
Linyi Cancer Hospital
Linyi, China
Not Yet Recruiting
Research Team
L
Lian Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here