Camrelizumab in Combination With Apatinib in Patients With Radioactive Iodine-refractory Differen… (NCT04560127) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Camrelizumab in Combination With Apatinib in Patients With Radioactive Iodine-refractory Differentiated Thyroid Cancer
China20 participantsStarted 2020-09-23
Plain-language summary
This is a single arm, open-label, non-randomized and single-center phase II clinical study, to evaluate the safety, tolerance, and efficacy of Camrelizumab in combination with Apatinib in patients with Radioactive Iodine-refractory Differentiated Thyroid Cancer (RAIR-DTC).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Lesions that do not demonstrate iodine uptake on any radioiodine scan.
✓. Subjects received a single radioactive iodine therapy within 12 months (≥ 3.7 Giga Bequerel（GBq）\[≥ 100 millicurie（mCi）\]) and target lesion disease progression.
✓. Every two radioactive iodine treatment interval \<12 months, doses ≥ 3.7 GBq \[≥100mCi\], disease progress more than 12 months after at least once iodine therapy.
✓. Received a total dose of radioactive iodine therapy ≥ 22.2 GBq (≥ 600 mCi). 6. Have the required screening laboratory values.
Exclusion criteria
✕. Other thyroid cancer histological subtypes (such as medullary carcinoma, lymphoma or sarcoma).
✕. Any active autoimmune disease or history of autoimmune disease and expected recurrence (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis); subjects with skin diseases that does no need systemic treatment, for example, leukoderma, psoriasis, alopecia, those with controlled type I diabetes by insulin or those with asthma that has been completely resolved in childhood and with no need of any intervention can be enrolled; while subjects with asthma who need bronchodilator for medical intervention cannot be enrolled.
✕. Use of strong CYP3A4/CYP2C19 inducers, including rifampicin (and its analogues) and St. John's Wort, or strong CYP3A4/CYP2C19 inhibitors within two weeks prior to signing informed consent form.
✕. Previous treatment with other immune checkpoint inhibitors (include PD-1 antibody or other immunotherapy against PD-1/PD-L1).
. Known history of serious allergy to any monoclonal antibody or Apatinib.
✕. Inability or unwilling to swallow tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption.
✕. Previous or current presence of metastasis to central nervous system.
✕. Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteremia or complications of severe pneumonia; oral or intravenous therapeutic antibiotics within two weeks prior to the start of study treatment (for example, subjects who are given with preventive antibiotics for prevention of urinary tract infection or exacerbation of chronic obstructive pulmonary disease are eligible for participation in the study).