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New treatment option for Leiomyosarcoma
Official title MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma
ClinicalTrials.gov ID: NCT06277154
What this study is testing
What is MASCT-I?
MASCT-I is an investigational medicine, being studied as a potential treatment for leiomyosarcoma.
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 evaluate the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide for first-line treatment in patients with advanced soft tissue sarcoma.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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 70
You may be able to join if
- Age≥18 years and≤70 years;
- According to WHO Classification of Tumours, 5th Edition, Volume 3: Soft Tissue and Bone Tumours, histopathologically or cytologically confirmed...
- No previous treatment with systematic chemotherapy or targeted therapy for advanced soft tissue sarcomas or whose disease progressed after 6months of...
- At least one measurable and assessable lesion defined by RECIST 1.1;
- ECOG performance status of 0-1;
You likely can't join if
- Previous treatment with targeted therapy, radiotherapy (radiotherapy to non-target lesions or disease progressed after radiotherapy could be...
- Highly differentiated liposarcoma, malignant perivascular epithelioid tumor, protuberant cutaneous fibrosarcoma, extraosseous osteosarcoma, solitary...
- Previous treatment with anthracyclines or anthraquinones and whose cumulative dose exceeds equivalent 200mg/m2 doxorubicin.
- Previous treatment with MASCT, or have received other cellular immunotherapy or anti-PD-1, anti-PD-L1 antibody therapy in the past 1 year.
- Use of immunosuppressive agents or systemic or inhaled local hormones (exceeding 10mg/day prednisone or its equivalent) and were still using them...
- Use of immunomodulators and were still using them within 2 weeks before randomization.
See the full eligibility criteria
- Age≥18 years and≤70 years;
- According to WHO Classification of Tumours, 5th Edition, Volume 3: Soft Tissue and Bone Tumours, histopathologically or cytologically confirmed unresectable locally advanced or metastatic soft tissue sarcomas, including...
- No previous treatment with systematic chemotherapy or targeted therapy for advanced soft tissue sarcomas or whose disease progressed after 6months of the end of neoadjuvant or adjuvant therapy.
- At least one measurable and assessable lesion defined by RECIST 1.1;
- ECOG performance status of 0-1;
- Estimated life expectancy≥6 months;
- Pulmonary function is basically normal;
- people with organ function as defined below (any blood components and growth factors are not allowed within 14 days before apheresis): a) Hemoglobin ≥90g/L; b) Leukocyte≥3.5x10\^9/L; c) The absolute neutrophil count...
- Obtain the written informed consent of the patient/legal representative;
- people with potential fertility must agree to use effective contraceptive measure during and within 6 months after the treatment period. HCG test for female with potential fertility must be negative before the study was...
- Previous treatment with targeted therapy, radiotherapy (radiotherapy to non-target lesions or disease progressed after radiotherapy could be included.) or other antineoplastic drugs such as anlotinib, gemcitabine...
- Highly differentiated liposarcoma, malignant perivascular epithelioid tumor, protuberant cutaneous fibrosarcoma, extraosseous osteosarcoma, solitary fibroma/hemangiopericytoma, acinous soft tissue sarcoma, extraosseous...
- Previous treatment with anthracyclines or anthraquinones and whose cumulative dose exceeds equivalent 200mg/m2 doxorubicin.
- Previous treatment with MASCT, or have received other cellular immunotherapy or anti-PD-1, anti-PD-L1 antibody therapy in the past 1 year.
- Use of immunosuppressive agents or systemic or inhaled local hormones (exceeding 10mg/day prednisone or its equivalent) and were still using them within 2 weeks before randomization.
- Use of immunomodulators and were still using them within 2 weeks before randomization.
- Allergic to sodium citrate or human albumin.
- people with uncontrolled pleural effusion and abdominal effusion requiring repeated drainage and with moderate or higher volume of pericardial effusion.
- Have known active central nervous system (CNS) or meningeal metastases. people with previously treated brain metastases may participate provided they are stable based on the following: 1) any neurologic symptoms have...
- Have any active autoimmune disease or history of autoimmune disease.
- people with active tuberculosis.
- people were infected with hepatitis B virus, hepatitis C virus or HIV, or syphilis.
- Severe cardiovascular disease, such as: (1) complete left bundle branch block or III atrioventricular block; (2) history of myocardial infarction, angioplasty, coronary artery bypass graft; (3) prolonged QT/QTc interval...
- people with history of thrombus or experienced a cerebrovascular accident within 6 months before randomization;
- Other malignant tumors (except cured skin basal cell carcinoma, prostate carcinoma in situ and cervical carcinoma in situ) in the past 5 years;
- Known history of organ transplantation or ready to receive an organ transplantation;
- people who have undergone major surgery or traumatic injury within 4 weeks before randomization;
- Those who have a history of alcohol dependence, psychotropic substance abuse and cannot abstain or have mental disorders.
- Surgery for soft tissue sarcoma is planned during the study.
- people have participated in another investigational trial within 4 weeks before randomization.
- Any condition that the investigator considers to be prejudicial to the subject or to the subject's inability to meet or perform the study requirements exists.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, 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.