Clinical trial · Interventional
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
NCT07547592CI-TRIAL-00109292not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms of Connective and Soft Tissue With an Unspecified Anatomical Site | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bev + Gem + Doc | Drug | — | UNRESOLVED |
| Gem + Doc | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bev + Gem + Doc
- description
- 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.
- interventionNames
- Drug: Bev + Gem + Doc
- type
- ACTIVE_COMPARATOR
- label
- Gem + Doc
- description
- * 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.
- interventionNames
- Drug: Gem + Doc
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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 2. Age ≥19 years, \<80 years 3. ECOG performance status of 0-1 4. Has at least 1 measurable lesion (as defined by RECIST v1.1). 5. 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) 6. Female patient of childbearing potential has a negative serum or urine pregnancy test for β-hCG 7. Able to provide written informed consent and comply with the protocol requirements Exclusion Criteria: 1. Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study 2. More than 3 prior cytotoxic agents 3. previously received treatment with bevacizumab, gemcitabine, or docetaxel 4. Unresolved toxicities from prior anticancer therapy ≥ Grade 2 according to NCI CTCAE, excluding alopecia, vitiligo, and laboratory abnormalities defined in the inclusion criteria 5. Major surgery within 28 days prior to randomization. 6. Active or prior documented autoimmune or inflammatory disorders 7. Unstable cardiovascular disease 8. Has an active infection requiring parenteral treatment 9. History of another primary malignancy 10. Uncontrolled or active CNS metastasis and/or carcinomatous meningitis 11. Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study 12. Pre-existing interstitial lung disease (ILD)
References
Publications (0)
Data not yet available
No reference posted for this study.