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New treatment option for Soft Tissue Sarcomas
Official title IO Combined With AI as First-line Treatment for Patients With Soft Tissue Sarcoma(TAIS)
ClinicalTrials.gov ID: NCT06849986
What this study is testing
What is Tislelizumab+liposomal doxorubicin+ifosfamide?
Tislelizumab+liposomal doxorubicin+ifosfamide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for soft tissue sarcomas.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age 18 to 75 years, regardless of gender;
- Patients with histopathologically confirmed undifferentiated sarcoma (except small round cell undifferentiated sarcoma), synovial 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;
- Expected survival of more than 3 months;
You likely can't join if
- Any of the following conditions will result in exclusion from the study:
- Previous treatment for advanced soft tissue sarcoma, except for those who relapsed more than six months after adjuvant therapy with a cumulative dose...
- 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...
- History of other tumors within the past five years, except for cured cervical cancer or skin basal cell carcinoma; for patients with post - radiation...
- Symptomatic brain or meningeal metastasis (unless the patient has been treated for more than 6 months, with negative imaging results within 4 weeks...
See the full eligibility criteria
- 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...
- 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;
- Expected survival of more than 3 months;
- Within 7 days prior to screening (including day 7), laboratory test data requirements: neutrophil count ≥1.5×10⁹/L, platelet count ≥90×10⁹/L, hemoglobin ≥90g/L (no blood transfusion within 14 days), serum total...
- Presence of measurable lesions according to RECIST 1.1 criteria;
- The subject (or their legal representative/guardian) must sign an informed consent form, indicating that they understand the purpose of this study, are aware of the necessary procedures, and are willing to participate...
- Any of the following conditions will result in exclusion from the study:
- 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...
- 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;
- Symptomatic brain or meningeal metastasis (unless the patient has been treated for more than 6 months, with negative imaging results within 4 weeks prior to enrollment, and stable tumor - related clinical symptoms at...
- Clinically significant active bleeding;
- Pregnant or lactating women; women of childbearing potential who have not taken adequate contraceptive measures;
- Alcohol abuse or drug addiction;
- Patients with active autoimmune diseases or a history of such diseases that may recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple...
- Patients who need to receive systemic corticosteroids (equivalent to \>10mg prednisone/day) within 14 days prior to enrollment or during the study, or those who require other immunosuppressive drug treatment. The use of...
- Failure of important organs or other severe diseases, including interstitial pneumonia, clinically significant coronary artery disease, cardiovascular disease, or myocardial infarction, congestive heart failure...
- History of human immunodeficiency virus infection, or other acquired or congenital immune deficiency diseases, or history of organ transplantation or stem cell transplantation;
- Patients with active chronic hepatitis B or active hepatitis C. HBV carriers, those with stable hepatitis B after drug treatment (DNA titer ≤10\^3 copies/ml), and those with cured hepatitis C (HCV RNA negative) are...
- Severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation, or other concomitant diseases that, in the opinion of the investigator, seriously endanger the safety of the...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.