RecruitingPhase 2NCT06637007

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


Sponsor

Shanxi Province Cancer Hospital

Enrollment

30 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Evaluation of the efficacy and safety of Xidabenzamide combined with AK112 for advanced bone and soft tissue sarcoma of second-line and above.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of chidamide (an epigenetic drug) and AK112 (a dual immunotherapy drug) for people with advanced bone and soft tissue sarcomas that stopped responding to first-line treatment. It includes many types of sarcoma such as synovial sarcoma, osteosarcoma, rhabdomyosarcoma, and others. **You may be eligible if...** - You are 18–75 years old with an advanced bone or soft tissue sarcoma confirmed by biopsy - Your cancer progressed during or after first-line standard treatment - You have at least one measurable tumor - Your general health score is 0–1 (ECOG) and expected survival is more than 3 months - Your blood counts and organ function meet the required levels **You may NOT be eligible if...** - You have certain excluded types of sarcoma (e.g., mesothelioma, gastrointestinal stromal tumor, alveolar soft tissue sarcoma, extra-osseous myxoid chondrosarcoma) - You have active brain metastases - You have received prior treatment with similar immunotherapy or epigenetic drugs - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGChidamide Tablets combined with AK112

Chidamide Tablets 30mg/day, po.Bid; AK112(10mg/kg or 20mg/kg), ivgtt, Q3W.


Locations(1)

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

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NCT06637007


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