A Phase 1 interventional study of Entinostat and VAC/VTC chemotherapy in Soft Tissue Sarcoma, sponsored by Beijing Tongren Hospital. Recruiting at 1 site in China. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Beijing Tongren Hospital · Phase 1, Interventional, and Treatment
Pediatric soft tissue sarcomas (STS) are a group of malignant tumors originating from primitive mesenchymal tissues and account for approximately 7% of childhood cancers. STS are broadly classified into rhabdomyosarcoma (RMS) and non-rhabdomyosarcoma soft tissue sarcoma (NRSTS). RMS accounts for approximately one half of pediatric STS.
As reported, PAX fusion-positive RMS is more aggressive than fusion-negative RMS, with higher metastatic potential and poorer prognosis. Based on the unmet therapeutic need in pediatric sarcoma with PAX-family abnormalities, this study is intended to evaluate the preliminary safety and antitumor activity of entinostat with or without chemontherapy.
Cohort 1: Entinostat Monotherapy cohort After completion of prior chemotherapy and/or radiotherapy, patients who have achieved CR/PR will receive entinostat as consolidation therapy.
Cohort 2: Entinostat Combination Cohort Patients with recurrent or progressive disease will receive entinostat in combination with alternating VAC/VTC chemotherapy. If prior treatment with the VAC/VTC regimen is ineffective because of resistance or is not tolerated for safety reasons, the investigator team will discuss and develop an individualized combination chemotherapy regimen.
1,691 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's planned enrollment of 16 is below the median of 40 across 1,300 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Beijing Tongren Hospital is the lead sponsor of 163 studies on the registry; 53 are open to participants now.
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Exclusion Criteria:
After completion of prior chemotherapy and/or radiotherapy, patients who have achieved CR/PR will receive entinostat as consolidation therapy.
Drug: Entinostat
Patients with recurrent or progressive disease will receive entinostat in combination with alternating VAC/VTC chemotherapy.
Drug: Entinostat · Drug: VAC/VTC chemotherapy
For patients aged 1-3 years or weighing \<40 kg: starting dose 3 mg orally once weekly, maintained at 3 mg. For patients aged \>3 years or weighing ≥40 kg: starting dose 3 mg orally once weekly, with gradual escalation to a maintenance dose of 5 mg, or a starting dose of 5 mg.
VAC regimen: vincristine 1.5 mg/m² on Day 1; dactinomycin 12-15 µg/kg on Days 1-5; and cyclophosphamide 300 mg/m² on Days 1-4. VTC regimen: vincristine 1.5 mg/m² on Day 1; topotecan 1.2 mg/m² on Days 1-5; and cyclophosphamide 250 mg/m² on Days 1-5. If prior treatment with the VAC/VTC regimen is ineffective because of resistance or is not tolerated for safety reasons, the investigator team will discuss and develop an individualized combination chemotherapy regimen
Safety: incidence of adverse events (AEs) and Grade ≥3 AEs according to NCI-CTCAE v5.0.
AEs will be coded using MedDRA and graded according to NCI-CTCAE v5.0.
Time frame: AE recorded from infromed consent to 28 days after treatment completion or initiation of another anticancer treatment, whichever occurs first.
Progress-free survival (PFS)
The time from the date of first study-drug administration to radiographic disease progression or death from any cause, whichever occurs first.
Time frame: 2 years
Objective response rate (ORR)
the proportion of participants achieving CR or PR according to RECIST v1.1
Time frame: 2 years
Disease control rate (DCR)
The proportion of participants achieving CR, PR, or SD according to RECIST v1.1.
Time frame: 2 years
Overall survival (OS)
The time from the first administration of study drug to death from any cause.
Time frame: 2 years
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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