Actively Recruiting
Study of Serplulimab, Lenvatinib, and Paclitaxel for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma After Prior Immunotherapy: A Prospective Single-Arm Trial
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
Researchers are evaluating the effectiveness of a combination treatment involving Serplulimab, Lenvatinib, and Paclitaxel for adults with advanced gastric or gastroesophageal junction adenocarcinoma who have previously undergone first-line immunotherapy. This prospective, single-arm, multicenter phase II trial aims to assess this treatment approach in patients who meet specific cancer and treatment history criteria. Participants receive Serplulimab at a dose of 300 mg intravenously every three weeks, Lenvatinib at 8 mg orally daily, and Paclitaxel (or its albumin-bound or liposome forms) at doses ranging from 135 to 175 mg/m2 or 260 mg/m2 every three weeks. All treatments are given in combination as a second-line therapy following prior immunotherapy. The study does not include separate extension or safety follow-up periods described in the source. Throughout the trial, participants undergo evaluations to measure treatment response using objective response rates at six months after the last participant's enrollment. Researchers monitor measurable disease based on RECIST 1.1 criteria and assess safety through laboratory tests, tissue sample collection for PD-L1 expression, and performance status checks. Participants are required to provide informed consent and meet organ function and other health criteria to participate.
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
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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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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