Last updated: January 18, 2022
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Thyroid Cancer
Treatment
N/AClinical Study ID
NCT04952493
ALTER-T002
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 RAItreatment
- At least one measurable lesion, with diameter ≥ 10mm measured by spiral MRI/CT scanper 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 andwithin another 6 months after it; who are not in the lactation period and examined asnegative in blood serum test or urine pregnancy test within 7 days before theresearch; The man patients who must agree to take contraceptive methods during theresearch and within another 6 months after it.
Exclusion
Exclusion Criteria:
- Patients who had previously received treatment with Antiangiogenic tyrosine kinaseinhibitors, such as: Anlotinib, apatinib and Lenvatinib.
- Patients who had previously received local treatment within 4 weeks or Participated inother anti-tumor clinical trials within 4 weeks.
- Patients with previous or current concurrent malignancies or solid organs or bonemarrow transplants within 5 years. Exceptions include basal cell carcinoma of theskin, squamous cell carcinoma of the skin, or in situ cervical cancer that hasundergone potentially curative therapy
- Unmitigated ≥ grade 2 toxicity (CTC AE 5.0) due to any prior treatment, excludingalopecia.
- 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 injurywithin 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 fourweeks prior to the first administration, or patients with unhealed wounds, fractures,ulcers.
- Patients with arterial or venous thromboembolic events occurred within 6 months, suchas cerebrovascular accident (including transient ischemic attack), deep veinthrombosis and pulmonary embolism.
Study Design
Total Participants: 42
Study Start date:
September 15, 2021
Estimated Completion Date:
July 20, 2024
Study Description
Connect with a study center
Peking Union Medical College Hospital
Beijing, 100730
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.