Last reviewed · How we verify
NCT03951571
Efficacy and Safety of Anlotinib in Adjuvant Therapy for High-grade Soft Tissue Sarcoma
Phase 2 trial testing Anlotinib Hydrochloride in Soft Tissue Sarcoma Adult in 88 participants. Completed in 31 December 2022.
1 June 2022
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 88 |
| Start date | 13 May 2019 |
| Primary completion | 1 June 2022 |
| Estimated completion | 31 December 2022 |
| Sites | 5 locations across China |
Drugs / interventions tested
- Anlotinib Hydrochloride
- Placebo Oral Tablet — full drug profile →
Conditions studied
- Soft Tissue Sarcoma Adult — all drugs for Soft Tissue Sarcoma Adult →
- High Grade Sarcoma — all drugs for High Grade Sarcoma →
Sponsor
Fudan University
Who can join
18 and older, any sex, with Soft Tissue Sarcoma Adult or High Grade Sarcoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the efficacy and safety of Anlotinib Hydrochloride Capsule combined with Best Supportive Therapy in the adjuvant treatment of patients with high-grade soft tissue sarcoma after operation, as compared with placebo combined with Best Supportive Therapy.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Anlotinib: A Novel Targeted Drug for Bone and Soft Tissue Sarcoma.
Li S. · · 2021 · cited 60× · PMID 34094958 · DOI 10.3389/fonc.2021.664853 -
Anlotinib versus Placebo as Adjuvant Therapy for Localized High-Grade Soft-Tissue Sarcomas: A Phase II, Double-Blinded, Randomized Controlled Trial.
Wang C, Hu X, Yang L, Xu Y, et al · · 2025 · cited 3× · PMID 39918552 · DOI 10.1158/1078-0432.ccr-24-2531 -
MAPK-targeted therapies in non-gastrointestinal stromal tumor soft tissue sarcomas: current landscape and future directions.
Al Jarroudi O, El Bairi K, Brahmi SA, Afqir S. · · 2025 · PMID 40909947 · DOI 10.3389/fonc.2025.1418537
Verify or expand the search:
- PubMed search for NCT03951571
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Anlotinib Hydrochloride
Trials testing the same drug.
- NCT05485350 — Anlotinib , Penpulimab Combined With SBRT for Metastatic Non-Small Cell Lung Cancer (NSCLC) · Phase 2 · unknown
- NCT04959500 — Newly Diagnosed Glioblastoma · Phase 2 · active not recruiting
- NCT05035914 — Anlotinib Combined With mXELIRI as Second-line Treatment of Advanced Colorectal Cancer · Phase 1, PHASE2 · unknown
- NCT04080843 — Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF Wild-type mCRC Patients · Phase 2 · completed
- NCT04111913 — A Study of Sequential Anlotinib Followed by EP Regimen Plus Concurrent Radiotherapy for Unresectable Stage III Non-small · Phase 2 · unknown
Other recruiting trials for Soft Tissue Sarcoma Adult
Currently open trials in the same condition.
- NCT07169344 — Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma · Phase 2 · recruiting
- NCT07173972 — Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma. · Phase 2 · recruiting
- NCT05352750 — Phase 1 Study of SON-1010 in Adult Patients With Advanced Solid Tumors · Phase 1 · active not recruiting
- NCT07432932 — Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients · recruiting
- NCT06385288 — Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcomas · NA · recruiting
Other Fudan University trials
Trials by the same sponsor.
- NCT06196671 — Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer · Phase 2 · not yet recruiting
- NCT07423611 — ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer · Phase 2 · not yet recruiting
- NCT07410559 — Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Bre · Phase 2 · not yet recruiting
- NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
- NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03951571 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fudan University
- Last refreshed: 14 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03951571.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing