Anlotinib or Penpulimab in Combination With RAI for DTC (NCT04952493) | Clinical Trial Compass
UnknownPhase 2
Anlotinib or Penpulimab in Combination With RAI for DTC
China42 participantsStarted 2021-09-15
Plain-language summary
The purpose of this study is to assess the efficacy and safety of anlotinib in combination with I-131 in locally advanced/metastatic differentiated thyroid cancer. Anlotinib may stop the growth of tumor cells and improve iodine uptake.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* local advanced or metastatic differentiated thyroid cancer (DTC)
* scheduled to receive RAI treatment.
* absence of good remission of RAI or may not get satisfactory remission from RAI treatment
* At least one measurable lesion, with diameter ≥ 10mm measured by spiral MRI/CT scan per RECIST1.1.
* Be 18 years of age or older, ECOG PS: 0-2. Life expectancy of at least 6 months.
* Main organs function is normal.
* The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it.
Exclusion Criteria:
* Patients who had previously received treatment with Antiangiogenic tyrosine kinase inhibitors, such as: Anlotinib, apatinib and Lenvatinib.
* Patients who had previously received local treatment within 4 weeks or Participated in other anti-tumor clinical trials within 4 weeks.
* Patients with previous or current concurrent malignancies or solid organs or bone marrow transplants within 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
* Unmitigated ≥ g…