Anlotinib or Penpulimab in Combination With RAI for DTC

  • STATUS
    Recruiting
  • End date
    Jul 20, 2024
  • participants needed
    42
  • sponsor
    Peking Union Medical College Hospital
Updated on 23 March 2022
ct scan
measurable disease
tumor cells

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.

Description

Primary Outcome Measures:

objective response rate (ORR)

Secondary Outcome Measures:

  1. Biochemical Response Rate (BRR) Biochemical response rate is defined as the percentage of subjects whose Tg was consecutive decreases more than 25% compared to baseline twice
  2. Disease Control Rate (DCR)
  3. Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
  4. Nuclear medicine functional imaging changes of target lesions The dynamic changes of I uptake and 18F-FDG PET/CT imaging

Details
Condition Thyroid Cancer
Treatment Anlotinib Hydrochloride, Penpulimab, Sodium Iodide I 131
Clinical Study IdentifierNCT04952493
SponsorPeking Union Medical College Hospital
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

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
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