A Phase 1 interventional study of Lenvatinib plus taxane drugs in HER2-negative Advanced Gastric Cancer, sponsored by Ruijin Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-29.
Sponsored by Ruijin Hospital · Phase 1, Interventional, and Treatment
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.
This study is being conducted to establish safety and preliminary efficacy of Lenvatinib plus taxane drugs treatment for HER2-negative advanced gastric cancer after failure of first-line treatment.
The study will adopt the "3+3" dose escalation design. All patients received a standard dose of chemotherapy: paclitaxel 135mg/m2 every 3 weeks or docetaxel 75mg/m2 every 3 weeks. 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.
In order to avoid the possible ineffectiveness caused by the patient being exposed to low doses, the initial dose of 4 mg was enrolled in 1 patient. If there is no obvious dose-limiting toxicity (DLT) after the first dose, the dose escalation adopts a "3+3" method from the 8mg dose: if none of the 3 subjects in the previous dose group has a DLT within 21 days, the next dose study will be carried out; if one subject in the group has DLT occurs, then 3 additional subjects should be added to the dose group; if the 3 subjects have 1 or more DLTs, the trial terminated and the previous dose was regarded as the maximum tolerated dose (MTD).
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 19 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 360 are open to participants now.
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Exclusion Criteria:
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
Drug: Lenvatinib plus taxane drugs
* Drug: Paclitaxel Dose: 135mg/m2 Other Name: PTX * Drug: Docetaxel Dose: 75mg/m2 Other Name: FA * Drug: Lenvatinib Dose: 4mg, 8mg, 12mg,16mg Other Name: FA
Adverse events
Incidence of DLT within 21 days of the first Lenvatinib application
Time frame: 4 weeks after the last administration
Incidence of Treatment Related adverse events (TRAEs)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 4 weeks after the last administration
Incidence of dose-limiting toxicities (DLTs)
All patients who have received at least one dose of treatment will be included in the safety analysis. Number of participants with dose-limiting toxicities as assessed by CTCAE v5.0
Time frame: 4 weeks after the last administration
Incidence of Treatment Emergent Adverse Event (TEAEs)
Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0
Time frame: 4 weeks after the last administration
Maximum tolerated dose of lenvatinib
Maximum tolerated dose of lenvatinib in combination with single-agent chemotherapy
Time frame: 4 weeks after the last administration
Objective response rate (ORR)
Objective Response Rate is defined as the percentage of patients with a documented complete response or partial response (CR + PR) based on RECIST v1.1.
Time frame: up to 12 months
Disease control rate (DCR) based on the researcher's evaluation
Disease control Rate is defined as the percentage of patients with a documented complete response or partial response or stable disease (CR + PR+SD) based on RECIST v1.1.
Time frame: up to 12 months
Duration of Remission (DOR) based on the researcher's evaluation
The duration of remission (DOR) is defined as the time interval between the subject's first recording of disease remission to the first recording of disease progression.
Time frame: up to 12 months
Progression-free survival (PFS) based on the researcher's evaluation
Progression-free survival (PFS) is defined as the time interval from the first treatment of the subject to the first recording of disease progression or death due to any cause, whichever occurs first.
Time frame: up to 12 months
Overall survival (OS)
Overall survival is defined as the time from signing ICF until death from any cause.
Time frame: up to 12 months
Exploratory Outcome
Dynamic contrast-enhanced ultrasound (DCE-US) was used to evaluate the the efficacy of anti-angiogenic therapy. Wash-in area under the curve (WiAUC) were quantitatively by DCE-US before the chemotherapy(d-4), d1 and 42 days after chemotherapy.
Time frame: up to 8 weeks
Exploratory Outcome
Mass spectrometry flow cytometry was used to detect the ratio and number of CD8+T cells on d0 and d42 after Lenvatinib therapy, and evaluates the correlation between changes in the immune microenvironment and the efficacy.
Time frame: up to 8 weeks
Plan to share: No
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Ruijin Hospital