A Randomized, Open-label Clinical Trial, Focus on the Safety and Efficacy of Anlotinib Hydrochloride in Combination With RAI in Patients With Local Advanced and Tyriod Cancer

• Status: Not yet recruiting
• Trial end date: 2024-07-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborator: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Criteria

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 ≥ grade 2 toxicity (CTC AE 5.0) due to any prior treatment, excluding alopecia.

• With kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus)

• Patients with pleural effusion or ascites.

• Patients with any severe and/or uncontrolled disease.

• Patients who underwent major surgery, open biopsy or significant traumatic injury within 4 weeks.

• Regardless of the severity, patients with any physical signs or history of bleeding, patients with bleeding or bleeding events greater than or equal to CTCAE 2 within four weeks prior to the first administration, or patients with unhealed wounds, fractures, ulcers.

• Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism.