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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neoplasms of Connective and Soft Tissue With an Unspecified Anatomical Site
• Intervention / Treatment: Drug: Bev + Gem + Doc; Drug: Gem + Doc

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hyo Song Kim, Professor; Phone Number: +82-2-2228-8123; Email: hyosong77@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate, ORR	Overall response rate (ORR) based on RECIST version 1.1	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	The earlier of the date of first documented progressive disease or death from the date of enrollment	2 year
Overall survival (OS)	From the date of treatment initiation to the date of death or last follow-up	2 year
Safety profile	Safety profile assessed using CTCAE (version 5.0)	2 year

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Polycyclic Compounds; Pregnanes; Steroids; Fused-Ring Compounds; Pregnenediones; Pregnenes; Hydroxycorticosteroids; Adrenal Cortex Hormones; Desoxycorticosterone
• Other Study ID Numbers: 4-2026-0242

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No