New drug cocktail aims to shrink Hard-to-Treat thyroid tumors
NCT ID NCT07193186
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial tests two drugs—anlotinib and benmelstobart—as a second-line treatment for people with advanced or metastatic differentiated thyroid cancer that has not responded to first-line therapy. The study will enroll 23 participants and measure how many see their tumors shrink. Treatment continues until the disease worsens or side effects become too severe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anlotinib and Benmelstobart
- What this could lead to
- If successful, this combination could offer a new second-line treatment option for people with advanced thyroid cancer that has stopped responding to initial therapy.
- What could go wrong
- This is a small, early-phase (phase II) study with only 23 participants. The treatment may not work for everyone and could cause side effects like fatigue, high blood pressure, or immune-related reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 23 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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; * 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. Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Mapping how thyroid tumors spread and what surgery leaves behind
- Antibody-Drug conjugate targets TROP-2 in Hard-to-Treat thyroid cancers
- Can a video keep thyroid cancer patients on track after surgery?
- Can doctors safely watch small thyroid cancers instead of removing them?
- Aortic graft used to rebuild windpipe in thyroid cancer surgery