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OncoMatch/Clinical Trials/NCT06637007

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

Is NCT06637007 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Chidamide Tablets combined with AK112 for sarcoma,soft tissue.

Phase 2RecruitingShanxi Province Cancer HospitalNCT06637007Data as of Jun 2026Location: China

Treatment: Chidamide Tablets combined with AK112Evaluation of the efficacy and safety of Xidabenzamide combined with AK112 for advanced bone and soft tissue sarcoma of second-line and above.

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Extracted eligibility criteria

Treatments studied

Other

Chidamide Tablets combined with AK112

Cancer type

Sarcoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

Prior therapy

Min 1 prior line

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

Lab requirements

Blood counts

hemoglobin ≥90g/L; ANC ≥1.5×10^9/L; platelet ≥80×10^9/L

Kidney function

serum creatinine ≤1.5 ULN or creatinine clearance rate ≥60 ml/min

Liver function

total bilirubin ≤1.5 ULN; ALT and AST ≤2.5 ULN (≤5 ULN with liver metastasis)

Cardiac function

LVEF ≥ low limit of normal (50%)

Adequate organ and bone marrow function ... Blood routine examination standard ... Biochemical tests ... Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) ≥ Low limit of normal (50%)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06637007 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior histone deacetylase inhibitor, immune checkpoint inhibitor, systemic anti-tumor therapy disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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