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

NCT06849986 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2501312-5
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Soft Tissue Sarcomas; Pleomorphic Liposarcoma; Malignant Peripheral Nerve Sheath Tumor (MPNST); Desmoplastic Small Round Cell Tumor; Angiosarcoma; Fibrosarcoma; Leiomyosarcoma

Keywords

soft tissue sarcoma; tislelizumab; doxorubicin; ifosfamide

Outcome Measures

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

Secondary Outcomes (3)

• PFS

  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.

• OS

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

• Health Questionnaire Form

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

Study Arms (1)

tislelizumab combined with AI

EXPERIMENTAL

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

Drug: Tislelizumab+liposomal doxorubicin+ifosfamide

Interventions

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

tislelizumab combined with AI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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 bilirubin ≤1.5 times the upper limit of normal (ULN); ALT and AST ≤2.5× ULN (≤5× ULN for patients with liver metastases); serum creatinine ≤1.5× ULN or creatinine clearance rate ≥50ml/min;
• 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 in this study.

You may not qualify if:

• 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;
• 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 the time of enrollment);
• 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 sclerosis, vasculitis, glomerulonephritis, etc.), or those at high risk (such as patients who have undergone organ transplantation and require immunosuppressive therapy). Autoimmune hypothyroidism requiring only hormone replacement therapy or skin diseases not requiring systemic treatment are excluded;
• 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 topical or inhaled corticosteroids, or short - term (≤7 days) use of corticosteroids for prevention or treatment of non - autoimmune, non - frequent allergic diseases is excluded;
• Failure of important organs or other severe diseases, including interstitial pneumonia, clinically significant coronary artery disease, cardiovascular disease, or myocardial infarction, congestive heart failure, unstable angina, symptomatic pericardial effusion, or unstable arrhythmia within 6 months prior to enrollment;
• 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 eligible for enrollment;
• 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 patient or affect the patient's ability to complete the study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (3)

• Judson I, Verweij J, Gelderblom H, Hartmann JT, Schoffski P, Blay JY, Kerst JM, Sufliarsky J, Whelan J, Hohenberger P, Krarup-Hansen A, Alcindor T, Marreaud S, Litiere S, Hermans C, Fisher C, Hogendoorn PC, dei Tos AP, van der Graaf WT; European Organisation and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Doxorubicin alone versus intensified doxorubicin plus ifosfamide for first-line treatment of advanced or metastatic soft-tissue sarcoma: a randomised controlled phase 3 trial. Lancet Oncol. 2014 Apr;15(4):415-23. doi: 10.1016/S1470-2045(14)70063-4. Epub 2014 Mar 5.

  PMID: 24618336 BACKGROUND

• Shi Y, Su H, Song Y, Jiang W, Sun X, Qian W, Zhang W, Gao Y, Jin Z, Zhou J, Jin C, Zou L, Qiu L, Li W, Yang J, Hou M, Zeng S, Zhang Q, Hu J, Zhou H, Xiong Y, Liu P. Safety and activity of sintilimab in patients with relapsed or refractory classical Hodgkin lymphoma (ORIENT-1): a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2019 Jan;6(1):e12-e19. doi: 10.1016/S2352-3026(18)30192-3.

  PMID: 30612710 BACKGROUND

• Tawbi HA, Burgess M, Bolejack V, Van Tine BA, Schuetze SM, Hu J, D'Angelo S, Attia S, Riedel RF, Priebat DA, Movva S, Davis LE, Okuno SH, Reed DR, Crowley J, Butterfield LH, Salazar R, Rodriguez-Canales J, Lazar AJ, Wistuba II, Baker LH, Maki RG, Reinke D, Patel S. Pembrolizumab in advanced soft-tissue sarcoma and bone sarcoma (SARC028): a multicentre, two-cohort, single-arm, open-label, phase 2 trial. Lancet Oncol. 2017 Nov;18(11):1493-1501. doi: 10.1016/S1470-2045(17)30624-1. Epub 2017 Oct 4.

  PMID: 28988646 BACKGROUND

MeSH Terms

Conditions

Sarcoma; Hemangiosarcoma; Fibrosarcoma; Leiomyosarcoma; Liposarcoma; Neurofibrosarcoma; Desmoplastic Small Round Cell Tumor

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Neoplasms, Adipose Tissue; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Central Study Contacts

Xin Liu

CONTACT

+86 13761503356; jeanettexin@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 27, 2025
• Study Start: February 25, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 8, 2026

Record last verified: 2025-03

Locations

CN (1)