Can a chemo drug keep sarcoma at bay? new trial aims to find out
NCT ID NCT06981637
First seen Jun 25, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This Phase 2 trial tests whether a chemotherapy drug called pegylated liposomal doxorubicin (PLD) can help people with advanced soft tissue sarcoma live longer without their cancer growing. Participants who have already responded to standard chemotherapy will either receive PLD every 4 weeks for up to 12 cycles or be closely monitored without treatment. The study aims to see if maintenance therapy delays cancer progression compared to active surveillance.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pegylated liposomal doxorubicin (a chemotherapy drug)
- What this could lead to
- If successful, this could provide a new maintenance option to delay cancer progression in advanced soft tissue sarcoma patients who have already responded to initial chemotherapy.
- What could go wrong
- This is a small Phase 2 trial with only 81 participants, so results may not be conclusive. The drug can cause side effects like heart damage or low blood counts, and it may not improve survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 81 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. A histologically confirmed advanced soft tissue sarcoma. Note that subtypes typically do not use chemotherapy as standard treatment are not allowed, such as alveolar soft part sarcoma, solitary fibrous tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma) 2. Patients received first-line anthracycline-based treatment for a minimum of 4 cycles and a maximum of 8 cycles. 3. The best response after first-line anthracycline-based treatment must be either a complete response, partial response, or stable disease as defined by RECIST 1.1. The best response should be attributed solely to systemic treatment and not to local therapy. All the patients must have at least one measurable tumor based on RECIST 1.1 before initiating first-line anthracycline-based treatment. 4. Patients must be randomized within 8 weeks of their last dose of anthracycline-based treatment 5. Patients have a life expectancy ≥ 3 months 6. Patients older than 18 years old. 7. ECOG performance status of 0 to 1. 8. Patients must have adequate organ function and marrow reserve measured within 7 days prior to randomization as defined below: 1. Hemoglobin ≥ 9.0 g/dL; 2. Absolute neutrophil count ≥ 1,500/mm3; 3. Platelets ≥ 100,000/mm3; 4. Total bilirubin ≤ 1.5 x upper normal limit; 5. AST(SGOT)/ALT(SGPT) ≤ 2.5 x upper normal limit; for patients with liver metastases AST(SGOT)/ALT(SGPT) ≤ 5 x upper normal limit is allowed; 6. Serum creatinine ≤ 1.5mg/dL or creatinine clearance ≥50ml/min; 7. All women of childbearing potential must have a negative pregnancy test obtained within 72 hours before starting therapy. 9. For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm. 10. Patients with reproductive potential must use effective contraception (hormone orbarrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after the completion of therapy. 11. Patients must be able to comply with study procedures and sign informed consent. Exclusion Criteria: 1. Known allergy history to PLD or other drugs of liposome-based formulation. 2. LVEF \< 50% at screening as determined by UCG or MUGA. 3. Serious non-healing wound, ulcer, or bone fracture not related to underlying sarcoma. 4. Major surgical procedure, open biopsy, significant traumatic injury, or radiotherapy within 21 days prior to randomization. 5. Severe, uncontrolled medical conditions including severe liver disease, heart disease, uncontrolled diabetes or hypertension, or pulmonary disease. 6. Psychiatric illness or social situation that would preclude study compliance. 7. Women with pregnant or breast feeding (a urine pregnancy test must be performed on all female patients who are of childbearing potential before entering the study, and the result must be negative. 8. Another previous malignancy diagnosed within the past 3 years. Patients with carcinoma in situ and stage I malignancy under active surveillance (no medical treatment needed) are allowed for enrollment. 9. Active CNS metastasis defined by clinical symptoms, cerebral edema, steroid or anti- convulsant requirement, or progressive growth. Patients with a history of CNS metastasis or cord compression are allowed in the study if they have been treated and are clinically stable. 10. Patients with active hepatitis B. However, patients with controlled hepatitis B under anti-viral agent are allowed.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chang Gung Memorial Hospital
RECRUITINGKaohsiung City, Taiwan
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China Medical University Hospital
RECRUITINGTaichung, Taiwan
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Kaohsiung Medical University Chung-Ho Memorial Hospital,
RECRUITINGKaohsiung City, Taiwan
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National Cheng Kung University Hospital
RECRUITINGTainan, Taiwan
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National Taiwan University Hospital
RECRUITINGTaipei, Taiwan
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Taipei Veterans General Hospital
RECRUITINGTaipei, Taiwan
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Tri-Service General Hospital
RECRUITINGTaipei, Taiwan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Patient's own immune cells fight advanced sarcoma?
- Can an immune-boosting drug make chemotherapy more effective against sarcoma?
- Immunotherapy boosts chemo against rare sarcomas?
- New mRNA shot targets Hard-to-Treat cancers in early human test
- Experimental combo targets Hard-to-Treat sarcomas
- New drug cocktail shows promise in slowing rare sarcoma