Trials / Recruiting
RecruitingNCT06637007
Phase II Clinical Trial of Chidamide Combined With AK112 for Second-line and Advanced Bone and Soft Tissue Sarcoma
Single Arm, Open Phase II Clinical Trial of Chidamide Combined With AK112 for Second-line and Advanced Bone and Soft Tissue Sarcoma
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Shanxi Province Cancer Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Evaluation of the efficacy and safety of Xidabenzamide combined with AK112 for advanced bone and soft tissue sarcoma of second-line and above.
Detailed description
Evaluation of the efficacy and safety of Xidabenzamide combined with AK112 for advanced bone and soft tissue sarcoma of second-line and above. Main objective: To explore the objective response rate (ORR) and progression free survival (PFS) of Xidabenzamide combined with AK112 for disease stability in advanced bone and soft tissue sarcoma of second-line and above Secondary objective: To explore the overall survival (OS), quality of life (QOL), safety, and tolerability indicators of Xidabenzamide combined with AK112 for advanced bone and soft tissue sarcoma of second-line and above.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Chidamide Tablets combined with AK112 | Chidamide Tablets 30mg/day, po.Bid; AK112（10mg/kg or 20mg/kg）, ivgtt, Q3W. |
Timeline
- Start date
- 2024-08-01
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
- First posted
- 2024-10-15
- Last updated
- 2024-10-15
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06637007. Inclusion in this directory is not an endorsement.