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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).
It is estimated that 10 patients who met the study criteria will be enrolled in 1 years and treated with Camrelizumab plus Apatinib in PUMCH. The investigators will follow up and collect subjects' data to evaluate the efficacy and safety of treatment, including objective response rate (ORR) and Progression-free Survival (PFS) and Overall Survival (OS), until disease progression or death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab combination with Apatinib | Experimental | Apatinib (250mg p.o. q.d.) combined with Camrelizumab (200mg, iv, q2w) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab combination with Apatinib | Drug | Apatinib (250mg p.o. q.d.) combined with Camrelizumab (200mg, iv, q2w) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients. | Time Frame: two years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Duration from the date of initial treatment to the date of death due to any cause. | two years |
| Progression-free Survival (PFS) | A duration from the date of initial treatment to disease progression (defined by RECIST 1.1) or death of any cause. |
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Inclusion Criteria:
1. Aged after 18 years (18 is included). 2. Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular, Hurthle cells, poorly differentiated carcinoma). At least one measurable lesion (helical CT scan long diameter ≥10mm, meet the requirements of the standard Response Evaluation Criteria In Solid Tumors(RESCIST) version 1.1).
3. ECOG-PS score 0-2 4. Life Expectancy of at least 12 weeks 5. Subjects must be 131I-refractory / resistant as defined by at least one of the following.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41408254 | Derived | Zhang X, Sun D, Zhang Y, Mu Z, Shi C, Sun Y, Cheng X, Meng C, Wei X, Liang J, Lin Y. Camrelizumab and apatinib in Chinese patients with locally advanced or metastatic radioiodine-refractory differentiated thyroid cancer: an exploratory open-label, single-arm trial. BMC Med. 2025 Dec 18;24(1):43. doi: 10.1186/s12916-025-04550-9. |
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| two year |
| Disease Control Rate (DCR) | Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit. | two year |
| Duration of Response (DoR) | Duration from the first time reported partial response or complete response to the first time of disease progression or death. | two year |
| Time to Progression (TTP) | A duration from the date of initial treatment to disease progression (defined by RECIST 1.1) | two year |
| Adverse events (AE) | Any adverse events related with treatment drugs and details include adverse events type, frequency and severity. | two years |
| ID | Term |
|---|---|
| C553458 | apatinib |
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