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A prospective, parallel controlled study of DEB-TACE versus arterial infusion chemotherapy in the treatment of metastatic or recurrent soft tissue sarcoma

A prospective, parallel controlled study of deb-tace versus arterial infusion chemotherapy in the treatment of metastatic or recurrent soft tissue sarcoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200060233
Enrollment
Unknown
Registered
2022-05-22
Start date
2022-05-13
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soft tissue sarcoma

Interventions

Drug elution embolism-Transcatheter arterial chemoembolization, DEB-TACE group:Drug elution embolism-Transcatheter arterial chemoembolization, DEB-TACE group
Arterial infusion chemotherapy group:Arterial infusion chemotherapy

Sponsors

The Fifth Medical Center of PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age >= 14 years old, male or female; 2. Patients with metastatic or recurrent soft tissue sarcoma confirmed by histopathology; 3. The metastatic or recurrent lesion is not suitable or the patient does not undergo surgical resection; 4. Patients who have previously received or are about to receive interventional therapy; 5. According to the mRECIST standard for solid tumors, and the patient has at least one measurable lesion; 6. The Eastern Cancer Collaborative Group (ECOG) physical fitness score is 0-3 points; 7. The expected survival period is >= 3 months; 8. Subjects volunteered to join the study, signed the informed consent form, had good compliance and cooperated with follow-up.

Exclusion criteria

Exclusion criteria: 1. Abnormal coagulation function, INR>1.5, or undergoing anticoagulation therapy or known hemorrhagic diseases; 2. White blood cells2 × ULN 4. Abnormal liver function, ALT or ASL>5 × ULN 5. Have a history of major diseases involving the heart, kidney, bone marrow, or lung, central nervous system; 6. Pregnant or lactating women, patients with fertility who are unwilling or unable to take effective contraceptive measures; 7. Serious infection during the active period or under clinical control, or severe infection within 4 weeks before enrollment; 8. Interpretation of research results; 9. Have a mental disorder or a history of abuse of psychotropic substances and are unable to quit; 10. Clinical trials involving other investigational drugs or devices within 4 weeks.

Design outcomes

Primary

MeasureTime frame
Progressive free survival, PFS;

Secondary

MeasureTime frame
Objective remission rate, ORR;Disease control rate, DCR;1-year survival rate;

Countries

China

Contacts

Public ContactJing Li

The Fifth Medical Center of PLA General Hospital

Lijing19792019@163.com+86 18501270097

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026