Actively Recruiting
Lenvatinib Plus Tislelizumab and CapeOX as First-Line Treatment for Advanced GC/GEJC With Positive PD-L1 and Low TMEscore
Led by Nanfang Hospital, Southern Medical University · Updated on 2025-05-30
92
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, prospective, phase II clinical study to evaluate the efficacy and safety of intensive treatment with lenvatinib plus tislelizumab and CapeOX as first-line treatment for advanced gastric cancer or gastroesophageal junction adenocarcinoma with PD-L1 positive and low TMEscore. A total of 92 subjects are randomly divided into study group and control group according to 1:1 ratio. Tislelizumab 200mg, iv, d1+ oxaliplatin 130mg/m2, iv, d1+ capecitabine 1000mg/m2, bid po, D1-14, q3w ± Lenvatinib 8mg, qd po regimen are received, respectively (3 weeks as a cycle, a maximum of 8 cycles of treatment). Then the maintenance treatment phase with tislelizumab ± lenvatinib is entered, and the specific dosage is the same as the treatment period. Effectiveness is assessed every 9 weeks (±7 days) until disease recurrence, metastasis, death, or loss of follow-up. The primary endpoint of this study was PFS, and secondary endpoints were OS, ORR, DoR, and DCR.
CONDITIONS
Official Title
Lenvatinib Plus Tislelizumab and CapeOX as First-Line Treatment for Advanced GC/GEJC With Positive PD-L1 and Low TMEscore
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily participate and provide informed consent with good compliance
- Age 18 years or older, any gender
- Histologically or cytologically confirmed advanced gastric cancer or gastroesophageal junction adenocarcinoma (stage IV)
- Tumor is PD-L1 positive and has a low tumor microenvironment score
- No prior systemic antitumor therapy, or previous adjuvant/neoadjuvant therapy completed over 6 months ago
- ECOG performance status between 0 and 2
- Expected survival of at least 12 weeks
- Adequate blood counts, liver function, and kidney function as defined
- Men and women of childbearing potential must use effective contraception
You will not qualify if you...
- Prior therapy targeting T cell co-stimulation or checkpoint pathways (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies)
- Prior anti-vascular small-molecule targeted drug therapy such as fuquinitinib or regofenib
- Major surgery within 4 weeks before first drug dose; radiotherapy or investigational tumor treatments within 2 weeks
- Live vaccine within 4 weeks before first drug dose (except inactivated flu vaccine)
- Severe intolerance to study drugs (grade 4 toxicity or higher)
- Allergy to study drugs or their components
- HER2 positive gastric cancer or gastroesophageal junction adenocarcinoma
- Other malignancies within past 5 years except certain cured early-stage cancers
- Known brain or meningeal metastases
- Organ or bone marrow transplant history or planned
- HIV infection history
- History of substance abuse
- Conditions affecting lung function or causing pulmonary toxicity
- Active or suspected autoimmune disease unless stable without immunosuppression
- Recent use of systemic corticosteroids or immunosuppressive agents beyond allowed doses
- Active infections needing treatment within 2 weeks before dosing
- Active heart disease including recent myocardial infarction or unstable angina
- Recent significant bleeding or clotting disorders
- Other diseases or conditions deemed unsuitable by the investigator
- Pregnant, lactating, or women who may become pregnant
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Trial Site Locations
Total: 1 location
1
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
Research Team
W
Wangjun Liao, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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