Lenvatinib Plus PD-1 Inhibitor for Advanced Solid Tumors With 11q13 Amplification
ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTongji Hospital
About this trial
The goal of this clinical trial is to learn if the combination of lenvatinib and a PD-1 inhibitor (a type of immunotherapy) works to treat advanced solid tumors that have a specific genetic change called "11q13 amplification". It will also learn about the safety of this combination. The main questions it aims to answer are:
How many participants' tumors shrink or stop growing after receiving the combination therapy? What side effects do participants have when taking this combination therapy? All participants in this study will receive the same drug combination. Researchers will look at the results to see how well the treatment works.
Participants will:
Take lenvatinib orally once daily and receive PD-1 inhibitor by intravenous infusion every 3 weeks.
Visit the clinic regularly for checkups, blood tests, and CT or MRI scans to see how the tumor is responding.
Be followed for side effects and survival over time.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary signing of the informed consent form, age ≥ 18 years at the time of signing, any gender.
Histologically or cytologically confirmed unresectable locally advanced or metastatic solid malignant tumor, including but not limited to: esophageal carcinoma, head and neck squamous cell carcinoma, breast cancer, lung cancer, hepatobiliary malignancies, and other solid tumors deemed eligible by the investigator.
Confirmed tumor presence of chromosome 11q13 amplification (amplification of at least one gene among CCND1, FGF3, FGF4, FGF19) via NGS testing.
No prior treatment with lenvatinib.
Disqualifiers
Presence of active or previously documented autoimmune or inflammatory disorders.
Known hypersensitivity to any component of the study drugs (lenvatinib or PD-1 inhibitors).
Significant bleeding tendency or coagulation dysfunction, or occurrence of major bleeding within 4 weeks prior to enrollment.
Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) despite medication.
Trial design
Design model
Single group
Treatments tested in this trial
Lenvatinib plus PD-1 Inhibitor
DrugThis is a combination therapy. Lenvatinib is administered orally once daily at a weight-based dose (12 mg for patients ≥60 kg; 8 mg for patients \<60 kg). The PD-1 inhibitor component is not fixed; specific agents (such as pembrolizumab, sintilimab, etc.) may be used according to institutional standards and drug availability. The PD-1 inhibitor is administered intravenously at a dose of 200 mg every 3 weeks. Treatment continues until disease progression, unacceptable toxicity, or other protocol-specified criteria for discontinuation are met.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Lenvatinib + PD-1 Inhibitor Combination TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR)
Proportion of participants achieving a best overall response of Complete Response (CR) or Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Tumor response will be assessed by investigators via contrast-enhanced CT or MRI scans.
Time frame
From first dose of study treatment until the first documented disease progression or start of new anticancer therapy, whichever occurs first, assessed up to approximately 24 months.Secondary outcomes
1
Disease Control Rate (DCR)
Time frame
From first dose until disease progression or start of new therapy, assessed up to 24 months.2
Progression-Free Survival (PFS)
Time frame
From first dose until progression or death, assessed up to 24 months.3
Overall Survival (OS)
Time frame
From first dose until death from any cause, assessed up to approximately 36 months.4
Incidence of Treatment-Related Adverse Events (TRAEs)
Time frame
From first dose until 30 days after the last dose.Other outcomes
1
Incidence of Hyperprogressive Disease (HPD)
HPD is defined as meeting all of the following three criteria based on RECIST 1.1: 1) Time-to-treatment failure (TTF) \< 2 months; 2) Progressive disease (PD) as the best overall response with ≥50% increase in the sum of target lesion diameters from baseline; 3) Tumor growth kinetics ratio (TGKR) ≥ 2, comparing the tumor growth rate during treatment to the pre-treatment rate.
Time frame
From first dose of study treatment until the first tumor assessment (approximately 8 weeks)Sponsors and contacts
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Source ClinicalTrials.gov