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Study of Sinibolimab Combined with Lenvatinib As Neoadjuvant Therapy for Locally Advanced Unresectable Differentiated Thyroid Carcinoma

NCT06848920 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-02-27

No results posted yet for this study

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. 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).

Conditions

  • Differentiated Thyroid Carcinoma (DTC)
  • Neoadjuvant Therapy

Interventions

DRUG

Immunotherapy combined with Multikinase inhibitors in neoadjuvant treatment

Sinibolimab combined with Lenvatinib in neoadjuvant treatment

Sponsors & Collaborators

  • Zhejiang University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2027-06-30
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06848920 on ClinicalTrials.gov