Differentiated Thyroid Carcinoma (DTC)Phase 2NCT06848920
Study of Sinibolimab Combined with Lenvatinib As Neoadjuvant Therapy for Locally Advanced Unresectable Differentiated Thyroid Carcinoma
A Phase 2 study testing Immunotherapy combined with Multikinase inhibitors in neoadjuvant treatment in people with Differentiated Thyroid Carcinoma (DTC) and Neoadjuvant Therapy, run by Zhejiang University at 1 site in China.
Trial summary
This study is a single-arm, prospective investigation aimed at evaluating the efficacy of Sinibolimab combined with Lenvatinib as neoadjuvant therapy for locally advanced unresectable differentiated thyroid carcinoma in a Phase II clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Differentiated Thyroid Carcinoma (DTC), Neoadjuvant Therapy
- What is being tested?
- Immunotherapy combined with Multikinase inhibitors in neoadjuvant treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed newly diagnosed or recurrent locally advanced (T4N1M0) differentiated thyroid carcinoma with an estimated risk of R2 resection.
- Performance Status (PS) score of 0-1. Age ≥ 18 years. Measurable lesions according to RECIST 1.1 criteria. Normal function of major organ systems.
Who cannot join
- Intratracheal airway tumors. Complete carotid artery encasement/invasion. Full-thickness infiltration of the esophageal wall. Arterial thrombosis/cancer thrombus. Active hemoptysis (bright red blood ≥ 1/2 teaspoon) or other uncontrolled bleeding within 21 days prior to study enrollment.
- History of prior neck radiotherapy. Previous treatment with Lenvatinib or immunotherapy. Participants with > 1+ proteinuria on urine dipstick will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein ≥ 1g/24 hours will be ineligible.
- Active, known, or suspected autoimmune diseases. Participants requiring long-term systemic corticosteroid therapy. Participants using bronchodilators, inhaled corticosteroids intermittently due to COPD or asthma, or those receiving local corticosteroid injections may be eligible.
- Active unstable angina and/or congestive heart failure. New-onset myocardial infarction within the last 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Qiangfeng Wang, +86-571-87235896, qiangfengwang@zju.edu.cn
About this study
Official title: Phase II Clinical Study of Sinibolimab Combined with Lenvatinib As Neoadjuvant Therapy for Locally Advanced Unresectable Differentiated Thyroid Carcinoma
This study is a single-arm, prospective investigation aimed at evaluating the efficacy of Sinibolimab combined with Lenvatinib as neoadjuvant therapy for locally advanced unresectable differentiated thyroid carcinoma in a Phase II clinical trial. The study plans to enroll 20 patients with locally advanced unresectable papillary thyroid carcinoma. Eligible participants will receive a combination of Sinibolimab and Lenvatinib for four cycles. After completing the four cycles of treatment, the tumor response will be assessed to determine the feasibility of surgical intervention. Participants who complete treatment will enter a follow-up period for safety monitoring and survival assessment. The primary endpoints of the study include the major pathological response (MPR) and the R0/R1 resection rate. Secondary endpoints include the objective response rate (ORR) after four cycles, 1-year and 2-year disease-free survival (DFS) rates, serious adverse events (SAE), and immune-related adverse events (irAE).
Read the detailed description
This study is a single-arm, prospective Phase II clinical trial designed to evaluate the efficacy and safety of Sinibolimab in combination with Lenvatinib as a neoadjuvant therapy for patients with locally advanced, unresectable differentiated thyroid carcinoma (DTC). A total of 20 patients with locally advanced unresectable papillary thyroid carcinoma (PTC) meeting eligibility criteria will be enrolled. Participants will receive four cycles of the combination therapy consisting of Sinibolimab, a PD-1 inhibitor, and Lenvatinib, a tyrosine kinase inhibitor known for its anti-angiogenic and anti-proliferative properties.
After completing the four treatment cycles, tumor response will be evaluated using imaging and pathological assessments to determine if surgical resection of the tumor becomes feasible. The primary endpoints are the major pathological response (MPR) after neoadjuvant therapy and the R0/R1 resection rate, which measures the proportion of patients achieving complete or near-complete tumor removal.
Secondary endpoints include objective response rate (ORR), defined as the proportion of patients exhibiting a measurable reduction in tumor size after four cycles, as well as 1-year and 2-year disease-free survival (DFS) rates. Additionally, the trial will comprehensively monitor treatment-related safety, focusing on the incidence of serious adverse events (SAEs) and immune-related adverse events (irAEs). Patients who complete the trial will enter a post-treatment follow-up phase to evaluate long-term outcomes, including survival and late-onset adverse effects.
This investigation will provide insight into the potential of Sinibolimab combined with Lenvatinib to convert unresectable tumors into resectable states, thereby improving therapeutic options for patients with advanced thyroid carcinoma.
- Being tested
- Immunotherapy combined with Multikinase inhibitors in neoadjuvant treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunotherapy combined with Multikinase inhibitors in neoadjuvant treatmentDrug
Sinibolimab combined with Lenvatinib in neoadjuvant treatment
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Sinibolimab combined with Lenvatinib group Receives: Drug: Immunotherapy combined with Multikinase inhibitors in neoadjuvant treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response rate (MPR)
Measured: After four cycles of treatment（each cycle is 21 days）
R0/R1 resection rate
R0 (no tumor at the surgical margins) / R1 (microscopically negative surgical margins) resection rates.
Measured: After four cycles of treatment（each cycle is 21 days）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Differentiated Thyroid Carcinoma (DTC)Studies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiongfei Yu, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848920
- Sponsor's protocol ID
- 2024102
- Status last verified
- Feb 2025
- First submitted
- 26 Jan 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Sinibolimab Combined with Lenvatinib As Neoadjuvant Therapy for Locally Advanced Unresectable Differentiated Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT06848920
- Acronym / sponsor ID
- 2024102
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-arm, prospective investigation aimed at evaluating the efficacy of Sinibolimab combined with Lenvatinib as neoadjuvant therapy for locally advanced unresectable differentiated thyroid carcinoma in a Phase II clinical trial. The study plans to enroll 20 patients with locally advanced unresectable papillary thyroid carcinoma. Eligible participants will receive a combination of Sinibolimab and Lenvatinib for four cycles. After completing the four cycles of treatment, the tumor response will be assessed to determine the feasibility of surgical intervention. Participants who complete treatment will enter a follow-up period for safety monitoring and survival assessment. The primary endpoints of the study include the major pathological response (MPR) and the R0/R1 resection rate. Secondary endpoints include the objective response rate (ORR) after four cycles, 1-year and 2-year disease-free survival (DFS) rates, serious adverse events (SAE), and immune-related adverse events (irAE).
Detailed description
This study is a single-arm, prospective Phase II clinical trial designed to evaluate the efficacy and safety of Sinibolimab in combination with Lenvatinib as a neoadjuvant therapy for patients with locally advanced, unresectable differentiated thyroid carcinoma (DTC). A total of 20 patients with locally advanced unresectable papillary thyroid carcinoma (PTC) meeting eligibility criteria will be enrolled. Participants will receive four cycles of the combination therapy consisting of Sinibolimab, a PD-1 inhibitor, and Lenvatinib, a tyrosine kinase inhibitor known for its anti-angiogenic and anti-proliferative properties.
After completing the four treatment cycles, tumor response will be evaluated using imaging and pathological assessments to determine if surgical resection of the tumor becomes feasible. The primary endpoints are the major pathological response (MPR) after neoadjuvant therapy and the R0/R1 resection rate, which measures the proportion of patients achieving complete or near-complete tumor removal.
Secondary endpoints include objective response rate (ORR), defined as the proportion of patients exhibiting a measurable reduction in tumor size after four cycles, as well as 1-year and 2-year disease-free survival (DFS) rates. Additionally, the trial will comprehensively monitor treatment-related safety, focusing on the incidence of serious adverse events (SAEs) and immune-related adverse events (irAEs). Patients who complete the trial will enter a post-treatment follow-up phase to evaluate long-term outcomes, including survival and late-onset adverse effects.
This investigation will provide insight into the potential of Sinibolimab combined with Lenvatinib to convert unresectable tumors into resectable states, thereby improving therapeutic options for patients with advanced thyroid carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Immunotherapy combined with Multikinase inhibitors in neoadjuvant treatmentSinibolimab combined with Lenvatinib group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically confirmed newly diagnosed or recurrent locally advanced (T4N1M0) differentiated thyroid carcinoma with an estimated risk of R2 resection.
- Performance Status (PS) score of 0-1. Age ≥ 18 years. Measurable lesions according to RECIST 1.1 criteria. Normal function of major organ systems.
Key exclusion criteria (4 listed)
- Intratracheal airway tumors. Complete carotid artery encasement/invasion. Full-thickness infiltration of the esophageal wall. Arterial thrombosis/cancer thrombus. Active hemoptysis (bright red blood ≥ 1/2 teaspoon) or other uncontrolled bleeding within 21 days prior to study enrollment.
- History of prior neck radiotherapy. Previous treatment with Lenvatinib or immunotherapy. Participants with > 1+ proteinuria on urine dipstick will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein ≥ 1g/24 hours will be ineligible.
- Active, known, or suspected autoimmune diseases. Participants requiring long-term systemic corticosteroid therapy. Participants using bronchodilators, inhaled corticosteroids intermittently due to COPD or asthma, or those receiving local corticosteroid injections may be eligible.
- Active unstable angina and/or congestive heart failure. New-onset myocardial infarction within the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunotherapy combined with Multikinase inhibitors in neoadjuvant treatmentSinibolimab combined with Lenvatinib in neoadjuvant treatment | Drug | Experimental group |
Primary outcome
Major pathological response rate (MPR)
Time frame: After four cycles of treatment（each cycle is 21 days）
R0/R1 resection rate
Time frame: After four cycles of treatment（each cycle is 21 days）
R0 (no tumor at the surgical margins) / R1 (microscopically negative surgical margins) resection rates.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immunotherapy combined with Multikinase inhibitors in neoadjuvant treatment in people with Differentiated Thyroid Carcinoma (DTC) and Neoadjuvant Therapy, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu, Professor (+86-571-87235896, 1100046@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathological response rate (MPR) (time frame: After four cycles of treatment（each cycle is 21 days）). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.