Utidelone Capsules Combined With Doxorubicin for Advanced Soft Tissue Sarcoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBeijing Biostar Pharmaceuticals Co., Ltd.
About this trial
This trial is an open, multicenter, phase II clinical trial evaluating the efficacy and safety of uterostatin capsules (UTD2) combined with doxorubicin and tislelizumab in the treatment of advanced soft tissue sarcoma. A total of 49 participants are planned to be enrolled. Participants who meet the inclusion criteria will receive UTD2 + doxorubicin + tislelizumab. Doxorubicin will be administered for a maximum of 6 cycles. Participants who have no tumor response or a non-progressive disease (CR, PR, SD) after discontinuation of doxorubicin will receive UTD2 + tislelizumab for maintenance treatment. Maintenance treatment will last for a maximum of 2 years, but tislelizumab monotherapy maintenance treatment will last for a maximum of 1 year.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fully understand the purpose, content, process of the trial and possible adverse reactions, voluntarily participate as a subject, and sign the informed consent form;
Age of 18-70 years old (including 18 and 70 years old) at the time of informed consent (ICF) signing, regardless of gender.
Histopathologically /cytologically confirmed unresectable locally advanced or metastatic soft tissue sarcoma (classified per the 5th WHO classification, including leiomyosarcoma, liposarcoma, angiosarcoma, epithelioid sarcoma, synovial sarcoma, undifferentiated pleomorphic sarcoma, malignant peripheral nerve sheath tumor, myxofibrosarcoma, pleomorphic rhabdomyosarcoma, etc.).
No prior systemic anti-tumor therapy for advanced soft tissue sarcoma. For participants with prior neoadjuvant or adjuvant therapy, disease progression must occur >6 months after the last treatment.
Disqualifiers
Within the 3 years prior to enrollment, the participant had suffered from other malignant tumors, excluding cured cases of skin basal cell carcinoma or skin squamous cell carcinoma, cervical carcinoma in situ, or thyroid papillary carcinoma.
Tumor subtypes including gastrointestinal stromal tumor, non-pleomorphic rhabdomyosarcoma, undifferentiated small round cell sarcoma, desmoplastic small round cell tumor, alveolar soft part sarcoma, clear cell sarcoma, etc.
The participant had previously received anthracycline-based treatment, or had contraindications to doxorubicin treatment (the relevant contraindications can be found in the doxorubicin instructions), or was assessed by the investigator as not suitable for doxorubicin treatment.
Participants with previous use of oltiderone.
Trial design
Design model
Single group
Treatments tested in this trial
UTD2 + tislelizumab + doxorubicin
DrugUTD2: 60 mg/m²/day, orally administered on an empty stomach on Days 1-5 of each cycle (no food 2 hours before and within 1 hour after taking the medication), once daily. Doxorubicin: 75 mg/m²/day, administered by intravenous infusion on Day 1 of each cycle. Doxorubicin is limited to a maximum of 6 cycles. Tislelizumab: 200 mg, administered by intravenous infusion on Day 1 of each cycle. Treatments were repeated every 3 weeks until disease progression (as assessed by the investigator according to RECIST v1.1), intolerable toxicity, withdrawal of informed consent by the participant, loss to follow-up, study termination, death, or when the investigator deemed it necessary to terminate medication or complete maintenance therapy, whichever occurred first.
Treatment groups
49 Participants
are divided into 1 treatment groupGroup A: UTD2 + tislelizumab + doxorubicinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-Free Survival, PFS
time from the first dose to disease progression or any-cause death
Time frame
up to 18 monthsSecondary outcomes
1
Objective Response Rate （ORR）according to the RECIST 1.1
ORR is defined as the percentage of participants in the analysis population who have CR or PR per RECIST 1.1.
Time frame
up to 18 months2
Disease Control Rate （DCR）according to the RECIST 1.1
DCR is defined as the percentage of participants in the analysis population who have CR or PR or SD per RECIST 1.1
Time frame
up to 18 months3
Duration of response (DoR) according to the RECIST 1.1
DoR is defined as the time from first CR or PR per RECIST 1.1 to first disease progression or death, whichever occurs first. Disease progression and censoring rules are identical to those for PFS.
Time frame
up to 18 months4
Treatment-related Adverse Event-TRAE
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame
Until 28 days after the last dose of treatmentSponsors and contacts
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Source ClinicalTrials.gov
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