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NCT03946943
Study of Anlotinib Hydrochloride and Toripalimab in Subjects With Unresectable or Metastatic Undifferentiated Pleomorphic Sarcoma
Phase 2 trial testing Anlotinib in Soft Tissue Sarcomas in 25 participants. Status unknown.
19 July 2022
Quick facts
| Lead sponsor | Di Wu |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 19 July 2019 |
| Primary completion | 19 July 2022 |
| Estimated completion | 19 July 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Anlotinib — full drug profile →
- Toripalimab (TORIPALIMAB) — full drug profile →
- Blood Draw — full drug profile →
- Tumor Specimen Collection
Conditions studied
- Soft Tissue Sarcomas — all drugs for Soft Tissue Sarcomas →
- Undifferentiated Pleomorphic Sarcoma — all drugs for Undifferentiated Pleomorphic Sarcoma →
Sponsor
Di Wu
Who can join
16 and older, any sex, with Soft Tissue Sarcomas or Undifferentiated Pleomorphic Sarcoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The investigators hypothesize that combination anlotinib with toripalimab will improve progression-free survival relative to historical controls in patients with Unresectable or Metastatic Undifferentiated Pleomorphic Sarcoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Anlotinib as a molecular targeted therapy for tumors.
Gao Y, Liu P, Shi R. · · 2020 · cited 108× · PMID 32724339 · DOI 10.3892/ol.2020.11685 -
Improving Immunotherapy Efficacy in Soft-Tissue Sarcomas: A Biomarker Driven and Histotype Tailored Review.
Roulleaux Dugage M, Nassif EF, Italiano A, Bahleda R. · · 2021 · cited 73× · PMID 34925348 · DOI 10.3389/fimmu.2021.775761 -
Anlotinib: A Novel Targeted Drug for Bone and Soft Tissue Sarcoma.
Li S. · · 2021 · cited 60× · PMID 34094958 · DOI 10.3389/fonc.2021.664853 -
Heterogeneous Circulating Tumor Cells in Sarcoma: Implication for Clinical Practice.
Agnoletto C, Caruso C, Garofalo C. · · 2021 · cited 12× · PMID 34063272 · DOI 10.3390/cancers13092189 -
Trends in clinical development of pediatric cancer for PD-1 and PD-L1 inhibitors: an analysis of ClinicalTrials.gov.
Que Y, Hu Y, Hong D, Zhang Y. · · 2021 · cited 11× · PMID 34583971 · DOI 10.1136/jitc-2021-002920 -
Immunotherapies for Pediatric Solid Tumors: A Targeted Update.
Gupta A, Cripe TP. · · 2022 · cited 10× · PMID 34822115 · DOI 10.1007/s40272-021-00482-y -
Enhancing the Potential of Immunotherapy in Paediatric Sarcomas: Breaking the Immunosuppressive Barrier with Receptor Tyrosine Kinase Inhibitors.
Fleuren EDG, Terry RL, Meyran D, Omer N, et al · · 2021 · cited 9× · PMID 34944614 · DOI 10.3390/biomedicines9121798 -
Genetic Heterogeneity of Undifferentiated Pleomorphic Sarcoma: Is There Potential for Targeted Therapy?
Lesovaya EA, Fetisov TI, Bokhyan BY, Senchenko MA, et al · · 2025 · PMID 41300979 · DOI 10.3390/cancers17223613
Verify or expand the search:
- PubMed search for NCT03946943
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Anlotinib
Trials testing the same drug.
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- NCT07537777 — Benmelstobart Plus Anlotinib Combined With SBRT for Patients With Hepatocellular Carcinoma Failing First-Line Targeted T · Phase 2 · not yet recruiting
- NCT07320963 — Chidamide in Combination With Toripalimab and Anlotinib in Recurrent/Metastatic Nasopharyngeal Carcinoma. · Phase 1, PHASE2 · not yet recruiting
- NCT07388875 — Sacituzumab Tirumotecan Plus Anlotinib in Previously Treated ES-SCLC · Phase 2 · not yet recruiting
- NCT07376499 — Prospective, Single-arm, Phase II Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Platinum a · Phase 2 · not yet recruiting
Other recruiting trials for Soft Tissue Sarcomas
Currently open trials in the same condition.
- NCT06849986 — IO Combined With AI as First-line Treatment for Patients With Soft Tissue Sarcoma(TAIS) · Phase 2 · recruiting
- NCT06593899 — The Total Neoadjuvant Therapy for Soft Tissue Sarcoma of the Extremities · Phase 2 · recruiting
- NCT04425967 — Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas · NA · active not recruiting
Other Di Wu trials
Trials by the same sponsor.
- NCT04979585 — Camrelizumab Plus Amlotinib and Chemotherapy in the First-line Treatment of Melanoma · Phase 2 · unknown
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 NCT03946943 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Di Wu
- Last refreshed: 10 July 2019
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/NCT03946943.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing