Anlotinib and Benmelstobart in DTC

Sponsor
Fudan University
Study ID
NCT07193186
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anlotinib and Benmelstobart — DRUG
    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 Details

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.

Key Dates

First listed
Sep 25, 2025
Start date
Apr 1, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
23 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Benmelstobart+Anlotinib

Primary Outcome Measure

Objective Response Rate，ORR [ Time Frame: 2 years ]

Central Contacts

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