Thyroid CancerPhase 2NCT07193186
Anlotinib and Benmelstobart in DTC
A Phase 2 study testing Anlotinib and Benmelstobart in people with Thyroid Cancer, run by Fudan University.
Trial summary
This study is a multicenter, open-label, phase II study to evaluate the efficacy and safety of Benmelstobart in combination with Anlotinib as a second-line treatment for locally advanced or metastatic differentiated thyroid cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Anlotinib and Benmelstobart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Dec 2030
- 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
- The patient voluntarily agrees to participate in this study and has signed the informed consent form;
- Age: ≥18 years, regardless of gender;
- Histologically confirmed differentiated thyroid cancer;
- Unresectable or borderline unresectable locally advanced thyroid cancer and/or metastatic thyroid adenocarcinoma;
- Failure of first-line treatment (failure to achieve partial or complete response) or disease progression after first-line treatment;
- At least one measurable lesion;
Show all 12Show fewer
- ECOG PS: 0-2;
- Expected survival period ≥12 weeks;
- Patient agrees to undergo tumor tissue biopsy/surgery at the time of enrollment;
- Normal function of major organs;
- Willingness to use reliable contraceptive methods during the trial. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment.
- The subject voluntarily agrees to participate in this study, signs the informed consent form, demonstrates good compliance, and cooperates with follow-up.
Who cannot join
- Presence of other active malignancies within the past 5 years or concurrently. Patients with cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc., may be enrolled.
- Use of other antitumor therapies (including but not limited to chemotherapy, radiotherapy, etc.) within 28 days prior to the first administration of the study drug. Thyrotropin (TSH) suppressive therapy is excluded.
- Prior treatment with immune checkpoint inhibitors (including but not limited to nivolumab, pembrolizumab, toripalimab, sintilimab, etc.).
- Any severe or uncontrolled systemic disease, as determined by the investigator, including poorly controlled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg) despite medication, uncontrolled diabetes, poorly managed cardiac disease, and signs of active bleeding.
- Known history of severe allergy to any monoclonal antibody or anti-angiogenic targeted drug.
- Presence of uncontrolled infection at the time of screening.
Show all 9Show fewer
- Pregnant or lactating women.
- Refusal to undergo tumor tissue biopsy at the time of enrollment.
- Other conditions considered by the treating physician as unsuitable for inclusion.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II Study of Anlotinib and Benmelstobart as Second-line Treatment in Locally Advanced or Metastatic Differentiated Thyroid Cancer
This study is a multicenter, open-label, phase II study to evaluate the efficacy and safety of Benmelstobart in combination with Anlotinib as a second-line treatment for locally advanced or metastatic differentiated thyroid cancer. Patients who meet the inclusion criteria and do not meet the exclusion criteria will receive Benmelstobart (1200mg, d1, q3w) in combination with Anlotinib (12mg, qd, d1-14, q3w). Treatment will continue until disease progression, voluntary withdrawal of informed consent, intolerable toxicity, or until the investigator determines that the patient no longer benefits. For locally advanced patients, if the disease converts from unresectable or borderline unresectable to resectable after treatment, surgical intervention will be performed.
- Conditions
- Thyroid Cancer
- Being tested
- Anlotinib and Benmelstobart
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib and BenmelstobartDrug
Patients will receive Benmelstobart (1200mg, d1, q3w) in combination with Anlotinib (12mg, qd, d1-14, q3w). Treatment will continue until disease progression, voluntary withdrawal of informed consent, intolerable toxicity, or until the investigator determines that the patient no longer benefits.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Benmelstobart+Anlotinib Receives: Drug: Anlotinib and Benmelstobart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate，ORR
Objective Response Rate (ORR) as assessed based on RECIST 1.1 criteria.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193186
- Sponsor's protocol ID
- ABILITY
- Status last verified
- Feb 2026
- First submitted
- 18 Sep 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Anlotinib and Benmelstobart as Second-line Treatment in Locally Advanced or Metastatic Differentiated Thyroid Cancer
- ClinicalTrials.gov ID
- NCT07193186
- Acronym / sponsor ID
- ABILITY
- Conditions
- Thyroid Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 25 Sep 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 multicenter, open-label, phase II study to evaluate the efficacy and safety of Benmelstobart in combination with Anlotinib as a second-line treatment for locally advanced or metastatic differentiated thyroid cancer. Patients who meet the inclusion criteria and do not meet the exclusion criteria will receive Benmelstobart (1200mg, d1, q3w) in combination with Anlotinib (12mg, qd, d1-14, q3w). Treatment will continue until disease progression, voluntary withdrawal of informed consent, intolerable toxicity, or until the investigator determines that the patient no longer benefits. For locally advanced patients, if the disease converts from unresectable or borderline unresectable to resectable after treatment, surgical intervention will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Anlotinib and BenmelstobartBenmelstobart+Anlotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The patient voluntarily agrees to participate in this study and has signed the informed consent form;
- Age: ≥18 years, regardless of gender;
- Histologically confirmed differentiated thyroid cancer;
- Unresectable or borderline unresectable locally advanced thyroid cancer and/or metastatic thyroid adenocarcinoma;
- Failure of first-line treatment (failure to achieve partial or complete response) or disease progression after first-line treatment;
Key exclusion criteria (9 listed)
- Presence of other active malignancies within the past 5 years or concurrently. Patients with cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc., may be enrolled.
- Use of other antitumor therapies (including but not limited to chemotherapy, radiotherapy, etc.) within 28 days prior to the first administration of the study drug. Thyrotropin (TSH) suppressive therapy is excluded.
- Prior treatment with immune checkpoint inhibitors (including but not limited to nivolumab, pembrolizumab, toripalimab, sintilimab, etc.).
- Any severe or uncontrolled systemic disease, as determined by the investigator, including poorly controlled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg) despite medication, uncontrolled diabetes, poorly managed cardiac disease, and signs of active bleeding.
- Known history of severe allergy to any monoclonal antibody or anti-angiogenic targeted drug.
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 |
|---|---|---|
| Anlotinib and BenmelstobartPatients will receive Benmelstobart (1200mg, d1, q3w) in combination with Anlotinib (12mg, qd, d1-14, q3w). Treatment will continue until disease progression, voluntary withdrawal of informed consent, intolerable toxicity, or until the investigator determines that the patient no longer benefits. | Drug | Treatment |
Primary outcome
Objective Response Rate，ORR
Time frame: 2 years
Objective Response Rate (ORR) as assessed based on RECIST 1.1 criteria.
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 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Thyroid Cancer
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
Recruiting
Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
Thyroid Gland Carcinoma
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib and Benmelstobart in people with Thyroid Cancer, run by Fudan University.
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 12 inclusion and 9 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 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Naisi Huang (86-021-64175590 ext. 67816, huangnaisi@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate，ORR (time frame: 2 years). 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 2026.