Phase II Clinical Trial of Chidamide Combined With AK112 for Second-line and Advanced Bone and Soft Tissue Sarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanxi Province Cancer Hospital
About this trial
Evaluation of the efficacy and safety of Xidabenzamide combined with AK112 for advanced bone and soft tissue sarcoma of second-line and above.
Eligibility criteria
Qualifiers
The patient voluntarily participated in this study and signed an informed consent form；
All advanced bone and soft tissue sarcomas diagnosed by pathology have at least one measurable lesion according to RECIST 1.1 criteria, mainly including synovial sarcoma, smooth muscle sarcoma, vascular sarcoma, undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma, liposarcoma, fibrosarcoma, clear cell sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undifferentiated sarcoma, rhabdomyosarcoma, protuberant skin fibrosarcoma, Ewing's sarcoma/primary neuroectodermal tumor, connective tissue proliferative small round cell tumor, inflammatory myofibroblastic sarcoma, malignant solitary fibroadenoma, chondrosarcoma, osteosarcoma. Except for the following types: malignant mesothelioma, acinar soft tissue sarcoma, gastrointestinal stromal tumor, and extra bone mucinous chondrosarcoma;
Patients with advanced bone and soft tissue sarcoma who experience disease progression or failure after first-line standard treatment;
18~75 years old; ECOG PS score: 0-1 points; Expected survival period exceeding 3 months;
Disqualifiers
Patients who have previously used sildenafil or other histone deacetylase inhibitors;
Previously received treatment with immune checkpoint inhibitors (PD-1, PD-L1, CTLA-4, etc.);
Other malignant tumors that have occurred or are currently present within the past 5 years, except for cured cervical carcinoma in situ, non melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)];
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;
Trial design
Treatments tested in this trial
- Chidamide Tablets combined with AK112
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov