Clinical trial · Interventional
Camrelizumab in Combination With Apatinib in Patients With Radioactive Iodine-refractory Differentiated Thyroid Cancer
A Single-arm, Non-randomized, Single-center Study to Evaluate Camrelizumab in Combination With Apatinib in Patients With Radioactive Iodine-refractory Differentiated Thyroid Cancer
NCT04560127CI-TRIAL-00091993active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radioactive Iodine-refractory Differentiated Thyroid Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab combination with Apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Camrelizumab combination with Apatinib
- description
- Apatinib (250mg p.o. q.d.) combined with Camrelizumab (200mg, iv, q2w)
- interventionNames
- Drug: Camrelizumab combination with Apatinib
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Time Frame: two years
- description
- 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.
Secondary outcomes (6)
- measure
- Overall Survival (OS)
- timeFrame
- two years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. 1. Lesions that do not demonstrate iodine uptake on any radioiodine scan. 2. Subjects received a single radioactive iodine therapy within 12 months (≥ 3.7 Giga Bequerel(GBq)\[≥ 100 millicurie(mCi)\]) and target lesion disease progression. 3. 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. 4. Received a total dose of radioactive iodine therapy ≥ 22.2 GBq (≥ 600 mCi). 6. Have the required screening laboratory values. Exclusion Criteria: 1. Other thyroid cancer histological subtypes (such as medullary carcinoma, lymphoma or sarcoma). 2. 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. 3. 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. 4. Previous treatment with other immune checkpoint inhibitors (include PD-1 antibody or other immunotherapy against PD-1/PD-L1). 5. Known history of serious allergy to any monoclonal antibody or Apatinib. 6. Inability or unwilling to swallow tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption. 7. Previous or current presence of metastasis to central nervous system. 8. 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). 9. Pregnant or lactating women. 10. Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators, such as alcoholism, drug abuse, other serious diseases (including mental disorders) requiring concomitant therapy, with serious laboratory examination abnormality, with family or social factors, that may affect subject's safety.
References
Publications (1)
- DERIVEDZhang 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. PMID 41408254