Combination treatment of pemetrexed and cisplatin for advanced soft tissue sarcoma
Official title: A Single-Arm, Multicenter, Open-Label, Phase 2 Study of Pemetrexed/Cisplatin Chemotherapy for Patients With Metastatic/Recurrent Soft Tissue Sarcoma in 4- Independent Histologic Subtypes
Run by Yonsei University · NCT04605770 · Data updated 2026-11-12
This study is testing if a combination of two cancer drugs, pemetrexed and cisplatin, can help people with advanced soft tissue sarcoma who haven't responded to standard treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 164 (estimated) |
| Sponsor | Yonsei University Academic / other |
| Drugs / interventions | chemotherapy, Doxorubicin |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | December 22, 2020 |
| Main results expected | November 1, 2027 |
| Study ends | November 1, 2027 |
| Registry record updated | April 30, 2026 |
| Trial ID | NCT04605770 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 19 and older with histologically confirmed advanced or metastatic soft tissue sarcoma and a performance status of 0 or 1.
✕Probably not a fit
Patients who have received more than two regimens of cytotoxic chemotherapy or have ongoing toxicity from previous treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the efficacy of a combination treatment using pemetrexed and cisplatin in patients with advanced or metastatic soft tissue sarcoma (STS) who have previously progressed after standard chemotherapy. The study aims to assess the response of these patients to the new treatment regimen, which may offer an alternative for those with limited options. Eligible participants must have measurable disease and adequate organ function, and they will be monitored for treatment outcomes and side effects throughout the trial.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced soft tissue sarcoma who have exhausted standard treatment options.
How similar studies have gone: While there have been studies on pemetrexed alone for refractory STS, the combination with cisplatin is a novel approach that has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * histologically confirmed, advanced/metastatic STS * Is ≥ 19 years of age * Eastern Cooperative Oncology Group performance status of 0 or 1 * measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 * laboratory values indicating adequate organ function * a documented postmenopausal woman, or is a premenopausal woman with negative urine or serum pregnancy test * life expectancy ≥ 12 weeks Exclusion Criteria: * previously received more than 2 regimens of cytotoxic chemotherapy * received chemotherapy, surgery to major organ, or radiotherapy within the last 2 weeks * ongoing toxicity (≥ CTCAE grade 2) from previous anticancer therapy * central nervous system (CNS) metastases requiring active treatment * diagnosis of second malignancy or has a history of active malignancy within the past 3 years * other medical conditions where the study treatment is intolerable * history of active infection * hypersensitivity to pemetrexed or any of its excipients * Co-administration with yellow fever vaccine * pregnancy
Where it's running
-
Severance Hospital
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Hyo Song Kim, MD, Ph.D
- Email: hyosong77@yuhs.ac
- Phone: 82-2-2228-8124
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Preventing heart problems in overweight/obese young sarcoma survivors with tirzepatide
This feasibility study tests whether tirzepatide can be safely given to overweight or obese young adults (18–39) who have completed doxorubicin for soft tissue or bone sarcoma to see if it’s feasible to use in the first year after therapy.
-
Personalized PULSAR radiotherapy for advanced small cell lung cancer and brain metastases
This trial will try personalized PULSAR radiotherapy schedules to see if they are safe and helpful for adults with extensive-stage small cell lung cancer who need thoracic radiation and for adults with 1–5 brain metastases.
-
Sequential CD146- and HER2-targeted CAR T-cell therapy for advanced sarcoma
This treatment will test whether giving a patient's own CAR T cells that target CD146 and HER2, one after the other, can shrink tumors in children and adults with relapsed or refractory advanced sarcoma.
-
Preventing wound complications after limb sarcoma surgery with a single-use negative-pressure dressing
This test will try a single-use negative-pressure wound dressing (PICO14) to see if it reduces wound complications after limb high-grade soft tissue sarcoma surgery in adults who received preoperative radiotherapy.
-
Total pre-surgery chemotherapy plus regional hyperthermia for high-risk limb and trunk soft tissue sarcoma (TNT-HYPE)
This trial will test whether giving three cycles of chemotherapy with regional hyperthermia before radiation and surgery is feasible and tolerable for people with high-risk soft tissue sarcoma of the arms, legs, or trunk.
-
Registry for Epithelioid Hemangioendothelioma
This study is collecting information from people newly diagnosed with epithelioid hemangioendothelioma to better understand the disease and how it’s treated.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.