Utidelone Capsules Combined With Doxorubicin for Advanced Soft Tissue Sarcoma

NCT07842276 | Not Yet Recruiting Phase 2

• 1 other identifier: BG02-2602
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is an open, multicenter, phase II clinical trial evaluating the efficacy and safety of uterostatin capsules (UTD2) combined with doxorubicin and tislelizumab in the treatment of advanced soft tissue sarcoma. A total of 49 participants are planned to be enrolled. Participants who meet the inclusion criteria will receive UTD2 + doxorubicin + tislelizumab. Doxorubicin will be administered for a maximum of 6 cycles. Participants who have no tumor response or a non-progressive disease (CR, PR, SD) after discontinuation of doxorubicin will receive UTD2 + tislelizumab for maintenance treatment. Maintenance treatment will last for a maximum of 2 years, but tislelizumab monotherapy maintenance treatment will last for a maximum of 1 year.

Conditions

Soft Tissue Sarcoma (STS); Utidelone; Doxorubicin

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival, PFS

  time from the first dose to disease progression or any-cause death

  up to 18 months

Secondary Outcomes (4)

• Objective Response Rate （ORR）according to the RECIST 1.1

  up to 18 months

• Disease Control Rate （DCR）according to the RECIST 1.1

  up to 18 months

• Duration of response (DoR) according to the RECIST 1.1

  up to 18 months

• Treatment-related Adverse Event-TRAE

  Until 28 days after the last dose of treatment

Study Arms (1)

UTD2 + tislelizumab + doxorubicin

EXPERIMENTAL

Drug: UTD2 + tislelizumab + doxorubicin

Interventions

UTD2 + tislelizumab + doxorubicin DRUG

UTD2: 60 mg/m²/day, orally administered on an empty stomach on Days 1-5 of each cycle (no food 2 hours before and within 1 hour after taking the medication), once daily. Doxorubicin: 75 mg/m²/day, administered by intravenous infusion on Day 1 of each cycle. Doxorubicin is limited to a maximum of 6 cycles. Tislelizumab: 200 mg, administered by intravenous infusion on Day 1 of each cycle. Treatments were repeated every 3 weeks until disease progression (as assessed by the investigator according to RECIST v1.1), intolerable toxicity, withdrawal of informed consent by the participant, loss to follow-up, study termination, death, or when the investigator deemed it necessary to terminate medication or complete maintenance therapy, whichever occurred first.

UTD2 + tislelizumab + doxorubicin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully understand the purpose, content, process of the trial and possible adverse reactions, voluntarily participate as a subject, and sign the informed consent form;
• Age of 18-70 years old (including 18 and 70 years old) at the time of informed consent (ICF) signing, regardless of gender.
• Histopathologically /cytologically confirmed unresectable locally advanced or metastatic soft tissue sarcoma (classified per the 5th WHO classification, including leiomyosarcoma, liposarcoma, angiosarcoma, epithelioid sarcoma, synovial sarcoma, undifferentiated pleomorphic sarcoma, malignant peripheral nerve sheath tumor, myxofibrosarcoma, pleomorphic rhabdomyosarcoma, etc.).
• No prior systemic anti-tumor therapy for advanced soft tissue sarcoma. For participants with prior neoadjuvant or adjuvant therapy, disease progression must occur \>6 months after the last treatment.
• At least one measurable lesion according to RECIST v1.1 definition.
• ECOG performance status of 0 or 1, with an expected survival of more than 12 weeks.
• Within 1 week before enrollment, the participant's blood routine examination was basically normal, and within 2 weeks before enrollment, the participant did not receive recombinant human granulocyte colony-stimulating factor (rhG-CSF) or blood products/erythropoietin (EPO).
• Absolute neutrophil count (ANC) ≥1.5×10⁹/L;
• Platelet count (PLT) ≥100×10⁹/L;
• Hemoglobin ≥9.0 g/dL.
• Blood biochemical examination was basically normal within 1 week before enrollment.
• Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN);
• Alanine aminotransferase (ALT) ≤3 × ULN (≤5 × ULN for participants with liver metastases);
• Aspartate aminotransferase (AST) ≤3 × ULN (≤5 × ULN for participants with liver metastases).
• Left ventricular ejection fraction (LVEF) of echocardiography is ≥ 55%.

You may not qualify if:

• Within the 3 years prior to enrollment, the participant had suffered from other malignant tumors, excluding cured cases of skin basal cell carcinoma or skin squamous cell carcinoma, cervical carcinoma in situ, or thyroid papillary carcinoma.
• Tumor subtypes including gastrointestinal stromal tumor, non-pleomorphic rhabdomyosarcoma, undifferentiated small round cell sarcoma, desmoplastic small round cell tumor, alveolar soft part sarcoma, clear cell sarcoma, etc.
• The participant had previously received anthracycline-based treatment, or had contraindications to doxorubicin treatment (the relevant contraindications can be found in the doxorubicin instructions), or was assessed by the investigator as not suitable for doxorubicin treatment.
• Participants with previous use of oltiderone.
• Within 2 weeks prior to enrollment, the participant had received traditional Chinese medicine or Chinese patent medicine with anti-tumor indications; within 2 weeks prior to enrollment, the participant had received local radiotherapy.
• Within 4 weeks prior to enrollment, the participant had undergone major surgical treatment, significant traumatic injury, or planned to undergo major surgery during the study period, or had long-standing unhealed wounds or fractures.
• Planned to receive surgical treatment, radiotherapy, or other systemic anti-tumor therapy for soft tissue sarcoma during the study.
• CTCAE 5.0 grade \> 1 for symptomatic peripheral neuropathy.
• The adverse effects of previous antineoplastic therapy have not recovered to CTCAE 5.0 grade ≤1 (except for toxicities without safety risk judged by investigators, such as alopecia).
• Tumor with active bleeding.
• Participants with symptomatic/uncontrolled central nervous system metastases or leptomeningeal metastases, including but not limited to participants with confirmed progressive brain metastases on imaging 2 months after radiotherapy or other local therapies, or participants deemed ineligible for enrollment by the investigator.
• Uncontrolled bone metastases, defined as participants with existing or imminent fracture risk, requiring surgery or local radiotherapy in the near term, or with other critical conditions as assessed by the investigator.
• Participants with uncontrolled pleural effusion or ascites requiring repeated drainage (once monthly or more frequently), and moderate or greater pericardial effusion.
• Participants with gastrointestinal diseases such as esophageal obstruction, pyloric obstruction, intestinal obstruction, or status post gastrointestinal resection, or other factors causing dysphagia that affect oral drug administration and absorption.
• History of severe cardiovascular and cerebrovascular diseases, including but not limited to:

Sponsors & Collaborators

• Beijing Biostar Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

West China Hospital Sichuan University

Chengdu, China

Location

MeSH Terms

Conditions

Sarcoma

Interventions

tislelizumab; Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Yu Jiang

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RONGGUO QIU, PhD

CONTACT

01186-56315388; rqiu2001@yahoo.com

Yu Jiang, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 25, 2026
• Study Start (Estimated): October 18, 2026
• Primary Completion (Estimated): September 20, 2028
• Study Completion (Estimated): December 20, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)