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 range
18 Years
Sex
ALL
See this in plain English?
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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).