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IO Combined With AI as First-line Treatment for Patients With Soft Tissue Sarcoma(TAIS)

ConditionsSoft Tissue SarcomasAngiosarcomaFibrosarcomaLeiomyosarcomaPleomorphic LiposarcomaMalignant Peripheral Nerve Sheath Tumor (MPNST)Desmoplastic Small Round Cell Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

About this trial

This study will enroll patients with specific subtypes of unresectable or metastatic soft tissue sarcoma, and will combine tislelizumab with the standard chemotherapy of liposomal doxorubicin and ifosfamide to initially explore the efficacy and safety.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 75 years, regardless of gender;

Patients with histopathologically confirmed undifferentiated sarcoma (except small round cell undifferentiated sarcoma), synovial sarcoma, angiosarcoma, fibrosarcoma, smooth muscle sarcoma, liposarcoma (except well differentiated liposarcoma), pleomorphic rhabdomyosarcoma, malignant peripheral nerve sheath meningiomas, desmoplastic small round cell tumor, not other specified (NOS), SMARCA4-deficient sarcoma, malignant phyllodes tumor of the breast, intimal sarcoma.

Patients with locally advanced disease that is not amenable to surgery/radiation therapy or with recurrent/metastatic disease;

Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1;

Disqualifiers

Previous treatment for advanced soft tissue sarcoma, except for those who relapsed more than six months after adjuvant therapy with a cumulative dose of doxorubicin ≤300mg/m2;

Received any experimental or anti - tumor drugs within 4 weeks prior to enrollment;

Previously received any anti - PD - 1, anti - PD - L1, anti - PD - L2, anti - CD137, or anti - CTLA - 4 antibody treatment, or any other antibodies or drugs specifically targeting T - cell co - stimulation or checkpoint pathways;

History of other tumors within the past five years, except for cured cervical cancer or skin basal cell carcinoma; for patients with post - radiation sarcoma, another primary tumor must have no recurrence or metastasis;

Trial design

Design model

Single group

Treatments tested in this trial

  • Tislelizumab+liposomal doxorubicin+ifosfamide

    Drug

    Liposomal Doxorubicin (PLD) 30mg/m2 on day 1 Ifosfamide (IFO) 3 g/m2/day on days 1 to 3 Tislelizumab 200mg on day 1, administered by intravenous infusion, every 3 weeks

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: tislelizumab combined with AIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR

Defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response and was assessed using RECIST 1.1 based on investigator evaluation.

Time frame
Time from the date of recruiting to the first recorded complete remission (CR) or partial remission (PR), assessed up to 36 months.

Secondary outcomes

1

PFS

Defined as the time from experiment drug administration to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on investigato evaluation.

Time frame
From the date of recruiting to the date of first recorded progression or death from any cause, whichever comes first, assessed up to 36 months.
2

OS

Defined as the time from experiment drug administration to death due to any cause

Time frame
From recruiting to the time of death from any cause, assessed up to 36 months.
3

Health Questionnaire Form

Health Questionnaire Form

Time frame
During the screening period, the second cycle and other even numbered cycles, each cycle is 21 days, assessed up to 36 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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