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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenvatinib + PD-1 Inhibitor Combination Therapy | Experimental | This is a basket trial arm. All enrolled participants, regardless of their specific solid tumor type (e.g., esophageal carcinoma, head and neck squamous cell carcinoma, etc.), receive the same intervention: the combination of lenvatinib and a PD-1 inhibitor. Patients are eligible if they have advanced solid tumors with chromosome 11q13 amplification. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenvatinib plus PD-1 Inhibitor | Drug | This 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | From first dose until disease progression or start of new therapy, assessed up to 24 months. | |
| Progression-Free Survival (PFS) | From first dose until progression or death, assessed up to 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang WU, M.D. | Contact | 13636076910 | 255001907@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Wuhan | Hubei | China |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
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|
| Overall Survival (OS) | From first dose until death from any cause, assessed up to approximately 36 months. |
| Incidence of Treatment-Related Adverse Events (TRAEs) | From first dose until 30 days after the last dose. |
| From first dose of study treatment until the first tumor assessment (approximately 8 weeks) |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |