Phase 2 Peripheral Neuropathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 70 years old
• People who have been diagnosed (through tissue or cell testing) with a soft tissue sarcoma that cannot be surgically removed, has spread locally, or has spread to other parts of the body — including specific types such as leiomyosarcoma, liposarcoma, synovial sarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumors, fibrosarcoma, pleomorphic rhabdomyosarcoma, endometrial stromal sarcoma, or desmoplastic small round cell tumor
• People who have not previously received chemotherapy or targeted therapy for advanced soft tissue sarcoma, or whose cancer came back more than 6 months after finishing earlier preventive (neoadjuvant or adjuvant) treatment
• People who have at least one tumour that can be measured and tracked using standard imaging criteria
• People who are generally well enough to carry out daily activities with no more than minor limitations (confirm with trial site for exact fitness level required)
• People with an estimated life expectancy of at least 6 months
• People whose lungs are functioning at a basically normal level
• People whose blood counts, liver, kidney, and other organ measurements meet specific levels set by the trial (confirm with trial site for exact values)
• People who are willing to give written consent to participate in the trial
• People who are able to use effective contraception during treatment and for 6 months after, and — for women who could become pregnant — a negative pregnancy test before joining

Who may not be able to join:

• People who have received targeted therapy, radiotherapy to a target lesion, or certain anti-cancer drugs (such as anlotinib or gemcitabine) within 4 weeks before joining, or anti-tumour Chinese medicine within 2 weeks before joining
• People whose specific sarcoma type is not considered suitable for the treatment combination used in this trial — including highly differentiated liposarcoma, gastrointestinal stromal tumour, Ewing's sarcoma, clear cell sarcoma, and several other specific subtypes (confirm with trial site for the full list)
• People who have previously received a certain class of chemotherapy drugs (anthracyclines or anthraquinones) at or above a total cumulative dose equivalent to 200 mg/m² of doxorubicin
• People who have previously received a specific type of immune cell therapy called MASCT, other cellular immunotherapy, or anti-PD-1 or anti-PD-L1 treatments within the past year
• People who have been using immunosuppressive medicines or steroid medicines (above a low threshold dose) within 2 weeks before joining
• People who have been using immune-modifying medicines within 2 weeks before joining
• People who have a known allergy to sodium citrate or human albumin
• People with uncontrolled fluid build-up around the lungs or abdomen requiring repeated draining, or moderate-to-large fluid build-up around the heart
• People with known active cancer spread to the brain or the lining of the brain, unless the brain metastases were previously treated, are now stable, and steroid medicine is no longer needed (or only a very low dose is being taken)
• People with an active autoimmune disease or a history of autoimmune disease
• People with active tuberculosis
• People with hepatitis B, hepatitis C, HIV, or syphilis infection
• People with serious heart conditions, including certain heart rhythm problems, a history of heart attack or bypass surgery, a prolonged heart electrical interval, reduced heart pumping function, heart failure, poorly controlled high blood pressure, or significant heart muscle disease or irregular heartbeat (confirm with trial site for exact measurements)
• People who have had a blood clot or stroke within 6 months before joining
• People who have had another cancer within the past 5 years, except for certain cured skin or in-situ cancers
• People with a history of organ transplant, or who are planning to receive one
• People who have had major surgery or a serious physical injury within 4 weeks before joining
• People with a history of alcohol dependence, misuse of controlled substances they are unable to stop, or a mental health disorder that could affect participation
• People who are planned to have surgery for their soft tissue sarcoma during the trial
• People who have participated in another clinical trial within 4 weeks before joining
• People with any other condition that the treating doctor considers would make participation unsafe or unsuitable

Important: Always verify eligibility with the trial site directly before applying.