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New treatment option for Gastric Cancer
Official title Lenvatinib Plus Tislelizumab and CapeOX as First-Line Treatment for Advanced GC/GEJC With Positive PD-L1 and Low TMEscore
ClinicalTrials.gov ID: NCT06157996
What this study is testing
What is lenvatinib and tislelizumab plus CapeOX chemotherapy?
lenvatinib and tislelizumab plus CapeOX chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients voluntarily participated in the study, signed the informed consent, and had good compliance;
- Age over 18 (including 18 years old), gender is not limited;
- Histologically and/or cytologically confirmed advanced gastric cancer or gastroesophageal junction adenocarcinoma (stage IV);
- Tumor with PD-L1 positive and low tumor microenvironment score (TMEscore)
- Have not received systemic antitumor therapy before; Or have previously received adjuvant or neoadjuvant therapy (chemotherapy/radiotherapy) for the...
You likely can't join if
- Previously received therapy that targets T cell co-stimulation or checkpoint pathways ,such as anti-PD-1 antibodies, anti-PD-L1 antibodies...
- Previously received anti-vascular small-molecule targeted drug therapy, such as fuquinitinib, regofenib, etc.;
- Received major surgery within 4 weeks prior to the first drug administration; radiotherapy, radiofrequency ablation and other investigational drugs...
- Received live vaccine within 4 weeks prior to the first drug administration (except inactivated viral vaccine for seasonal influenza);
- A history of severe intolerance to drugs involved in the study (i.e., grade 4 toxicity of one of these drugs; Class 3-4 toxicity of other...
- Known allergy to the study drug or any of its excipients;
See the full eligibility criteria
- Patients voluntarily participated in the study, signed the informed consent, and had good compliance;
- Age over 18 (including 18 years old), gender is not limited;
- Histologically and/or cytologically confirmed advanced gastric cancer or gastroesophageal junction adenocarcinoma (stage IV);
- Tumor with PD-L1 positive and low tumor microenvironment score (TMEscore)
- Have not received systemic antitumor therapy before; Or have previously received adjuvant or neoadjuvant therapy (chemotherapy/radiotherapy) for the purpose of cure, and the time of tumor recurrence \> 6 months since...
- ECOG performance status of 0-2 points;
- Expected survival ≥12 weeks;
- Blood test (without blood transfusion within 14 days) 1) Neutrophil absolute value ≥1.5×10\^9/L, platelet ≥100×10\^9/L, hemoglobin ≥90g/L); 2) Liver function test (aspartate aminotransferase and glutamate...
- Men and women of childbearing age must use effective contraceptive methods.
- Previously received therapy that targets T cell co-stimulation or checkpoint pathways ,such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.;
- Previously received anti-vascular small-molecule targeted drug therapy, such as fuquinitinib, regofenib, etc.;
- Received major surgery within 4 weeks prior to the first drug administration; radiotherapy, radiofrequency ablation and other investigational drugs for tumors within 2 weeks;
- Received live vaccine within 4 weeks prior to the first drug administration (except inactivated viral vaccine for seasonal influenza);
- A history of severe intolerance to drugs involved in the study (i.e., grade 4 toxicity of one of these drugs; Class 3-4 toxicity of other co-administered drugs is not excluded);
- Known allergy to the study drug or any of its excipients;
- HER2 positive gastric cancer or gastroesophageal junction adenocarcinoma;
- The patient had other malignancies within the previous 5 years or at the same time (except cured basal cell carcinoma, stage I squamous cell carcinoma, in situ carcinoma, intramucosal carcinoma, and superficial bladder...
- Known brain or meningeal metastases;
- Patients who are preparing for or have previously received an organ or bone marrow transplant;
- A history of human immunodeficiency virus (HIV) infection;
- A history of psychotropic substance abuse or drug use;
- Condition that may interfere with the detection and management of suspected drug-related pulmonary toxicity, such as interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severe...
- Known active or suspected autoimmune disease (except for patients with stable disease at enrollment who do not require systemic immunosuppressive therapy);
- Patients who required systemic corticosteroids (\> 10 mg/ day how well it works dose of prednisone) or other immunosuppressive agents within 2 weeks prior to initial administration or during the study period. However...
- Any active infection that requires systematic anti-infective treatment occurs within 2 weeks prior to the first dose (expect prophylactic antibiotic therapy, such as for urinary tract infections or chronic obstructive...
- Active heart disease, including myocardial infarction, severe/unstable angina in the 6 months prior to treatment. Echocardiography showed that the left ventricular ejection fraction was less than 50%, indicating poor...
- Obvious clinical bleeding symptoms or obvious bleeding tendency and hemoptysis within 3 months prior to treatment. Or treatment of venous/venous thrombosis events within the preceding 6 months, such as cerebrovascular...
- Any other disease, a clinically significant metabolic abnormality, abnormal physical examination or abnormal laboratory examination, for which, in the investigator's judgment, there is reason to suspect that the patient...
- Anything that, in the investigator's opinion, could put people receiving the study drug at risk, interfere with the study drug, subject safety assessment, or interpretation of the results;
- Pregnant or lactating women or women who may become pregnant.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.