Health Condition 1: C73- Malignant neoplasm of thyroid gland
Conditions
Interventions
Intervention1: Lenvatinib: Lenvatinib is an oral multi-kinase inhibitor that inhibits VEGFR1, VEGFR2, VEGFR3, FGFR1-4, PDGFR alpha, RET and KIT signalling pathway.
Lenvatinib will be administered as
Sponsors
Nil
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged between 18 and 70 years 2. Histologically confirmed diagnosis of differentiated thyroid cancer likepapillary, follicular, or Hurthle cell carcinoma. 3. Locally advanced disease likeT4, unresectable cases including unresectable nodes,based on clinical and radiological evaluation. 4. Recurrent differentiated thyroid cancer or metastatic disease. 5. Measurable disease according to RECIST 1.1 criteria. 6. ECOG performance status of 0 to2. 7. Adequate organ function, as demonstrated by laboratory values within normal limits
Exclusion criteria
Exclusion criteria: 1. Anaplastic or medullary thyroid carcinoma. 2. Patients with previous chemotherapy or targeted therapy for thyroid carcinoma . 3. Known allergic reactions to Lenvatinib or any of its components. 4. Significant cardiovascular disease like uncontrolled hypertension, congestive heart failure, recent myocardial infarction. 5. Active infection or other significant comorbidities. 6. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety and Tolerability of Lenvatinib: Evaluated based on the frequency and severity of adverse effects. 2. Surgical Outcomes: Evaluation of the ability to achieve R0 resection with preservation of vital structures.Timepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tumor shrinkage and downstaging: The change in tumor size based on RECIST 1.1 criteria before and after Lenvatinib treatment 2.Evaluation of response assessment according to demographic characteristics. Timepoint: 2 years | — |
Countries
India
Contacts
Public ContactSutirtha Saha
All India Institute of Medical Sciences
Outcome results
None listed