Anlotinib Plus Sintilimab for BRAF V600E Negative Unresectable or Metastatic Anaplastic Thyroid Carcinoma: A Single-Center, Single-Arm, Phase 2 Trial
Authors' conclusion
Anlotinib plus sintilimab showed favorable efficacy and manageable safety in BRAFV600E-negative unresectable or metastatic ATC, supporting further investigation.
Study context
- Population
- Patients with BRAFV600E-negative unresectable or metastatic anaplastic thyroid carcinoma (ATC)
- Participants
- 21 patients
- Outcome
- Investigator-assessed objective response rate (ORR)
Methodological detailssingle-centre, phase 2, Enrolment December 27, 2022 to June 11, 2025
- Single-centre
- Phase 2
- Enrolment December 27, 2022 to June 11, 2025
Main finding
As reported in the abstract
Investigator-assessed ORR
Objective response rate (ORR)
47.6%
10/21
Complete response
1
4.8%
Partial response
9
42.9%
Further findings
Disease control rate
- Disease control rate
- 85.7% (18/21)
Progression-free survival (PFS) · median follow-up 9.97 months (CI 6.10 to NA)
- Median PFS
- 9.63 months (CI 4.03 to NA)
- Still on treatment
- 8 (38.1%)
PFS by neutrophil-lymphocyte ratio <3.06 vs ≥3.06 (subgroup)
- Longer PFS with neutrophil-lymphocyte ratio <3.06: 18.43 vs 3.67 months
- P = 0.010
PFS by neutrophil-lymphocyte ratio <5 vs ≥5 (subgroup)
- Longer PFS with neutrophil-lymphocyte ratio <5: 14.23 vs 2.67 months
- P = 0.002
Overall survival
- Median overall survival not reached
- CI 13.90 to NA
- Remained alive
- 15 (71.4%)
Treatment discontinuation
- Discontinued treatment
- 61.9% (13/21)
- Due to disease progression
- 7/21, 33.3%
- Due to adverse events (AEs)
- 2/21, 9.5%
- Other reasons
- 4/21, 19.0%
Safety
Adverse events
- Any AE
- 14/21 (66.7%)
- Grade 3 AEs
- 4/21 (19.0%)
- AST increased
- 6/21 (28.6%)
- ALT increased
- 5/21 (23.8%)
- Grade 3 immune-related AEs (AST/ALT increased, diarrhea, hypertension, hypertriglyceridemia)
- 3 patients
Original publication
Anlotinib Plus Sintilimab for BRAF V600E Negative Unresectable or Metastatic Anaplastic Thyroid Carcinoma: A Single-Center, Single-Arm, Phase 2 Trial. Thyroid. Published 24 January 2026. doi:10.
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