Clinical trial · Interventional
A Clinical Trial to Evaluate the Efficacy and Safety of Anotinib Hydrochloride Capsule Combined With Epirubicin Hydrochloride Versus Placebo Combined With Epirubicin Hydrochloride in First-line Treatment of Advanced Soft Tissue Sarcoma
A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of Anotinib Hydrochloride Capsule Combined With Epirubicin Hydrochloride Versus Placebo Combined With Epirubicin Hydrochloride in First-line Treatment of Advanced Soft Tissue Sarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A multicenter, randomized, double-blind, parallel-controlled Phase III trial to evaluate the efficacy and safety of anotinib hydrochloride capsule combined with epirubicin hydrochloride versus placebo combined with epirubicin hydrochloride in first-line treatment of advanced soft tissue sarcoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib hydrochloride capsule | Drug | — | UNRESOLVED |
| Arotinib hydrochloride capsule placebo | Drug | — | UNRESOLVED |
| Epirubicin | Drug | Epirubicin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arotinib hydrochloride capsule + Epirubicin
- description
- Arotinib hydrochloride capsule combined with epirubicin, 21 days as a treatment cycle
- interventionNames
- Drug: Anlotinib hydrochloride capsule
- Drug: Epirubicin
- type
- ACTIVE_COMPARATOR
- label
- Placebo + Epirubicin
- description
- Placebo combined with epirubicin, 21 days as a treatment cycle
- interventionNames
- Drug: Epirubicin
- Drug: Arotinib hydrochloride capsule placebo
Primary outcomes (1)
- measure
- Progression free survival (PFS) assessed by independent review committees (IRC)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. * Life expectancy \>=3 months. * Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped. * Understood and signed an informed consent form. Exclusion Criteria: * Diagnosed and/or treated additional malignancy within 5 years before the first dose. * With factors affecting oral medication. * Received major surgical treatment, open biopsy or obvious traumatic injury within 4 weeks before the first dose. * A history of psychotropic drug abuse or have a mental disorder. * Any severe and/or uncontrolled diseas. * Has received Chinese patent medicines with anti-tumor indications within 2 weeks before the first dose. * Has participated in other clinical studies within 4 weeks before the first dose. * According to the judgement of the investigators, there are other factors that subjects are not suitable for the study.
References
Publications (0)
Data not yet available