Phase II Clinical Trial of Chidamide Combined With AK112 for Second-line and Advanced Bone and Soft Tissue Sarcoma

Must have received: standard treatment — first-line

Patients with advanced bone and soft tissue sarcoma who experience disease progression or failure after first-line standard treatment

Cannot have received: histone deacetylase inhibitor (sildenafil)

Patients who have previously used sildenafil or other histone deacetylase inhibitors

Cannot have received: immune checkpoint inhibitor

Previously received treatment with immune checkpoint inhibitors (PD-1, PD-L1, CTLA-4, etc.)

Cannot have received: systemic anti-tumor therapy

Received systemic anti-tumor therapy, including chemotherapy, immunotherapy, and biological therapy (such as tumor vaccines, cytokines, or growth factors that control cancer), within 28 days before starting the research treatment

Cannot have received: Chinese herbal medicine or traditional Chinese patent medicines with anti-tumor indications

Have received Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications within 7 days before starting the research treatment

Cannot have received: systemic anti-tumor therapy (mitomycin C)

Planned systemic anti-tumor therapy within 4 weeks prior to enrollment or during the study medication period, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or use of mitomycin C within 6 weeks prior to receiving experimental drug treatment)

Cannot have received: radiation therapy

Expanded field radiation therapy (EF-RT) was performed within 4 weeks prior to enrollment, or limited field radiation therapy was performed within 2 weeks prior to grouping to assess tumor lesions

Cannot have received: major surgery

Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to enrollment

Cannot have received: other anti-tumor drugs (clinical trial participation)

Participated in clinical trials of other anti-tumor drugs within 28 days prior to enrollment