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Not yet recruiting NCT07547592

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

Phase II Interventional Neoplasms of Connective and Soft Tissue With an Unspecified Anatomical Site

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bev + Gem + Doc, Gem + Doc.
Who it may be relevant to
Registry conditions: Neoplasms of Connective and Soft Tissue With an Unspecified Anatomical Site. Basic parameters: 18 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Bev + Gem + Doc
    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.
  • Drug Gem + Doc
    * 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 outcome measures

  • Overall Response Rate, ORR [Time frame: 2 year]
Secondary outcome measures (3)
  • Progression-free survival (PFS) [Time frame: 2 year]
  • Overall survival (OS) [Time frame: 2 year]
  • Safety profile [Time frame: 2 year]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07547592 · 4-2026-0242

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗