NCT07547592Not yet recruitingPhase 2
Gemcitabine and Docetaxel With or Without Bevacizumab (Onbevzi) for Soft Tissue Sarcoma
Phase II, Randomized Trial of Gemcitabine and Docetaxel With or Without Bevacizumab (Onbevzi) for Previously Treated Soft Tissue Sarcoma
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Brief summary (registry, in English)
Arm1- bevacizumab (Onbevzi) at a dose of 15 mg/kg administered as a 30-minute intravenous infusion on Day 1 of each 21-day cycle, followed by intravenous infusion of gemcitabine and docetaxel in sequence. On Day 8 of each cycle, gemcitabine and docetaxel will be administered as a 60-minute intravenous infusion. Arm2- On Day 1 of each 21-day cycle, gemcitabine will be administered first, followed by docetaxel as an intravenous infusion. On Day 8, gemcitabine and docetaxel will be administered as intravenous infusions.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 92 (estimated)
- First submitted
- 16 Apr 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- Yonsei University
- Diseases
- Sarcoma
- NCT number
- NCT07547592
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 92
- From 1 Jun 2026 to the primary completion date, 30 Nov 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study
- More than 3 prior cytotoxic agents
- previously received treatment with bevacizumab, gemcitabine, or docetaxel
- Major surgery within 28 days prior to randomization.
- Active or prior documented autoimmune or inflammatory disorders
Other illness
- Unstable cardiovascular disease
- Has an active infection requiring parenteral treatment
- History of another primary malignancy
- Pre-existing interstitial lung disease (ILD)
Lab values
- Unresolved toxicities from prior anticancer therapy ≥ Grade 2 according to NCI CTCAE, excluding alopecia, vitiligo, and laboratory abnormalities defined in the inclusion criteria
Other
- Uncontrolled or active CNS metastasis and/or carcinomatous meningitis
- Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
Who the study is looking for
- Histologically confirmed advanced leiomyosarcoma, undifferentiated pleomorphic sarcoma (UPS), liposarcoma, or angiosarcoma with 1-2 prior chemotherapy
- : neoadjuvnat or adjuvant chemotherapy is counted as one regimen
- Age ≥19 years, \<80 years
- ECOG performance status of 0-1
- Has at least 1 measurable lesion (as defined by RECIST v1.1).
- Has adequate organ function defined by the following criteria:
- Hb ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1500 /µL
- Platelet ≥ 75,000/ µL
- Total Bilirubin: ≤ 1.5 × UNL (upper normal limit) (≤ 2 × UNL in patients with liver metastasis)
- Serum Creatinine: ≥ 50 mL/min
- AST(SGOT)/ALT(SGPT): ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver metastasis)
- Alkaline Phosphatase (ALP): ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver or bone metastasis)
- Female patient of childbearing potential has a negative serum or urine pregnancy test for β-hCG
- Able to provide written informed consent and comply with the protocol requirements
Age in the registry: 18 years to 79 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.