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NCT Number: NCT07547592

Gemcitabine and Docetaxel With or Without Bevacizumab (Onbevzi) for Soft Tissue Sarcoma

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.

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Key information

Conditions

Neoplasms of Connective and Soft Tissue With an Unspecified Anatomical Site

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Unresolved toxicities from prior anticancer therapy ≥ Grade 2 according to NCI CTCAE, excluding alopecia, vitiligo, and laboratory abnormalities defined in the inclusion criteria
  • Major surgery within 28 days prior to randomization.
  • Active or prior documented autoimmune or inflammatory disorders
  • Unstable cardiovascular disease
  • Has an active infection requiring parenteral treatment
  • History of another primary malignancy
  • 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
  • Pre-existing interstitial lung disease (ILD)

Treatment and study plan

Bev + Gem + Doc

Drug

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.

Gem + Doc

Drug
  • Gemcitabine 1,000 mg/m² IV on Days 1 and 8 of each 21-day cycle (administered over 30 minutes)
  • Docetaxel 35 mg/m² IV on Days 1 and 8 of each 21-day cycle (administered over 60 minutes) 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.

Primary outcomes

  1. Overall Response Rate, ORR

    Time frame: 2 year

    Overall response rate (ORR) based on RECIST version 1.1

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: 2 year

    The earlier of the date of first documented progressive disease or death from the date of enrollment

  2. Overall survival (OS)

    Time frame: 2 year

    From the date of treatment initiation to the date of death or last follow-up

  3. Safety profile

    Time frame: 2 year

    Safety profile assessed using CTCAE (version 5.0)

Study contacts

Contact information is provided by the study sponsor or research team.

Hyo Song Kim, Professor

CONTACT

[email protected]

+82-2-2228-8123

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Phase II, Randomized Trial of Gemcitabine and Docetaxel With or Without Bevacizumab (Onbevzi) for Previously Treated Soft Tissue Sarcoma

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.