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NCT05941325
A Single-arm, Open-label, Single-center Prospective Study of Fruquintinib Combined With Envafolimab in the Treatment of Advanced or Unresectable Locally Advanced Bone and Soft Tissue Sarcoma
Phase 2 trial testing fruquintinib in Advanced or Unresectable Locally Advanced Bone and Soft Tissue Sarcoma in 20 participants. Currently enrolling.
1 December 2025
Quick facts
| Lead sponsor | Shanghai 6th People's Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 April 2023 |
| Primary completion | 1 December 2025 |
| Estimated completion | 1 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- fruquintinib — full drug profile →
- Envafolimab — full drug profile →
Conditions studied
- Advanced or Unresectable Locally Advanced Bone and Soft Tissue Sarcoma — all drugs for Advanced or Unresectable Locally Advanced Bone and Soft Tissue Sarcoma →
Sponsor
Shanghai 6th People's Hospital
Who can join
Adults 12 to 70, any sex, with Advanced or Unresectable Locally Advanced Bone and Soft Tissue Sarcoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Many osteosarcomas are cured with a variety of combined chemotherapy and surgery, but a significant number will still relapse.VEGF promotes an immunosuppressive microenvironment and contributes to immune checkpoint inhibitor resistance in cancer.We aimed to explore the efficacy and safety of fruquintinib combined immunotherapy for bone and soft tissue sarcoma.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05941325
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of fruquintinib
Trials testing the same drug.
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- NCT06584032 — Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer · Phase 3 · recruiting
- NCT05993702 — TAS-102 in Combination With Regorafenib or Fruquintinib for Third-line and Above Advanced Colorectal Cancer · unknown
- NCT04179084 — Phase II Study to Evaluate the Efficacy and Safety of Fruquintinib Plus Sintilimab as Third-line Therapy for Colorectal · Phase 2 · unknown
Other Shanghai 6th People's Hospital trials
Trials by the same sponsor.
- NCT07482891 — An Exploratory Study on Efficacy and Safety of Fosaprepitant and Palonosetron Hydrochloride for Injection in Preventing · Phase 4 · not yet recruiting
- NCT07414277 — CGM for Insulin-Treated T2DM During Post-Discharge Transition · NA · not yet recruiting
- NCT07359053 — MAGNATE-S: Paclitaxel Polymer Micelles Combo in Advanced Sarcoma · Phase 2 · recruiting
- NCT07288372 — The CGM-OGTT Glycemic Homeostasis Study · not yet recruiting
- NCT06936657 — Intervention Effects of Optimized Carbohydrate Diet in Patients With Type 2 Diabetes · NA · 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 NCT05941325 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai 6th People's Hospital
- Last refreshed: 18 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/NCT05941325.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing