Clinical trial · Interventional
Lenvatinib With Taxane Drugs Treatment for Advanced Gastric Cancer
An Exploratory Clinical Study of Lenvatinib Combined With Single-agent Taxanes as Second-line Therapy for the Treatment of HER2-negative Advanced Gastric Cancer
NCT05171530CI-TRIAL-00055698unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to study the safety and efficacy of lenvatinib combined with single-agent taxanes therapy in patients with HER2-negative advanced gastric cancer that have failed at the standard first-line therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-negative Advanced Gastric Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib plus taxane drugs | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lenvatinib with taxane drugs treatment for advanced gastric cancer
- description
- Experimental: Lenvatinib plus taxane drugs The subjects in this arm will receive a Lenvatinib combined with single-agent taxanes therapy. A standard dose of chemotherapy: paclitaxel 135mg/m2 every 3 weeks or docetaxel 75mg/m2 every 3 weeks will be administrated. Lenvatinib is exploring four doses of 4mg, 8mg, 12mg, and 16mg, orally once a day every 3 weeks. In the first cycle, lenvatinib was administered 5 days before chemotherapy，once a day. Chemotherapy lasts up to 6 cycles, and lenvatinib continues to be administered until the disease progresses, intolerable side effects, or death. Subjects will be enrolled serially. For subject safety, the preceding subject must have completed therapy and there is no obvious DLT within 21 days before the next subject can be treated. Interventions: * Drug: Paclitaxel or Docetaxel * Drug: Lenvatinib
- interventionNames
- Drug: Lenvatinib plus taxane drugs
Primary outcomes (5)
- measure
- Adverse events
- timeFrame
- 4 weeks after the last administration
- description
- Incidence of DLT within 21 days of the first Lenvatinib application
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ability to understand and the willingness to provide written informed consent. 2. Advanced gastric cancer diagnosed by histopathological or cytological examination, no uncontrollable pleural and ascites;. 3. Age no less than 18 years. 4. Life expectancy greater than 3 months. 5. According to the RECIST (Response Evaluation Criteria in Solid Tumors) standard, there must be measurable lesions. 6. Failed at the standard first-line therapy, microsatellite stable (MSS) or no mismatch repair missing(PMMR), HER2 negative. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 . 8. Adequate liver/bone marrow function. 9. Female subjects must meet the following conditions: infertility or fertility and use high-efficiency contraceptive measures. 10. Male subjects agree to use approved contraceptive methods (e.g. birth control pills, barrier device, intrauterine device, abstinence) during the study and for 3 months following the last dose of the study cell infusion. Moreover, all men are absolutely prohibited from donating sperm within 1 year after receiving the last study treatment infusion. Exclusion Criteria: 1. Previous use of lenvatinib or chemotherapy drugs in the regimen. 2. Pregnant or breast-feeding female, or not willing to take contraception measures during study. 3. Uncontrolled brain metastasis or mental illness. 4. Suffered from other uncured malignant tumors within the past 3 years or at the same time. 5. A history of active gastrointestinal bleeding within 3 months, incomplete obstruction or complete intestinal obstruction. 6. Uncontrollable high blood pressure are not suitable for enroll into the study. 7. Other uncontrolled diseases may cause abnormal death of the patient. 8. Untolerable liver/bone marrow function. 9. Factors that affect the administration of oral drugs (dysphagia, chronic diarrhea, complete intestinal obstruction, etc. 10. Previously allergic to the ingredients of the medicine in regimen. 11. Can't be followed up or obey protocol. 12. The investigator believes that it is not appropriate to participate in the trial.
References
Publications (0)
Data not yet available
No reference posted for this study.