Anlotinib or Penpulimab in Combination With RAI for DTC

Last updated: January 18, 2022
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Thyroid Cancer

Treatment

N/A

Clinical Study ID

NCT04952493
ALTER-T002
  • Ages > 18
  • All Genders

Study 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.

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

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

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, 100730
    China

    Active - Recruiting

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