Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 19 and up

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.

More Sarcoma,Soft Tissue trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages19 Years and up
SexAll
Enrollment164 (estimated)
SponsorYonsei University
Academic / other
Drugs / interventionschemotherapy, Doxorubicin
Locations1 site (Seoul)
StatusRecruiting
StartedDecember 22, 2020
Main results expectedNovember 1, 2027
Study endsNovember 1, 2027
Registry record updatedApril 30, 2026
Trial IDNCT04605770 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.