AzTrials
AzTrials

Soft Tissue SarcomaPhase 2NCT05497843

Chiauranib for Advanced or Unresectable Soft Tissue Sarcoma(STS)

A Phase 2 study testing Chiauranib in people with Soft Tissue Sarcoma, run by Chipscreen Biosciences, Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase 2, single-arm, open-label study in patients with advanced or unresectable soft tissue sarcoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Soft Tissue Sarcoma
What is being tested?
Chiauranib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
25 Aug 2022to 3 Jan 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, age ≥ 18 years and ≤75 years.
  • Histologically confirmed advanced or unresectable soft tissue sarcoma with failure of standard therapy or no standard therapy.
  • At least one measurable target lesion as defined by RECIST1.1, i.e., a lesion that has radiologic evidence of disease progression, after treatment with radiotherapy or local-regional therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Laboratory criteria are as follows:
  • Hematology: absolute neutrophil count (ANC) ≥1.5×109/L, platelet ≥75×109/L, hemoglobin ≥80 g/L.
Show all 10Show fewer
  • Biochemistry: serum creatinine <1.5×upper limit of normal (ULN), total bilirubin ≤1.5×ULN, both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN for patients with hepatic metastasis).
  • Coagulation panel: international normalized ratio (INR) <1.5.
  • Life expectancy of at least 3 months.
  • Willingness to sign a written informed consent document.

Who cannot join

  • Active central nervous system (CNS) symptoms during the screening period and/or CNS metastases requiring hormone therapy within 28 days before the first dose, or lesions involving the brain stem or pia mater.
  • Imaging during the screening period showed that the tumor had invaded the periphery of the important blood vessels or the investigator judged that the tumor was likely to invade the important blood vessels and cause massive bleeding during the trial.
  • Pleural fluid, ascites or pericardial effusion with significant symptoms or required treatment of puncture or drainage during the screening period.
  • Current or previous history of other malignancies (other than adequately treated basal or squamous cell carcinoma of the skin or cervical carcinoma in situ) unless curative treatment has been performed and there is no evidence of recurrence or metastasis in the last 5 years
  • Prior treatment with vascular endothelial growth factor(VEGF)/vascular endothelial growth factor receptor(VEGFR) inhibitor, like Apatinib, Anlotinib, Fruquintinib, Bevacizumab, etc., or Aurora kinase inhibitors (For patients eligible for anlotinib, only those who could not receive anlotinib for various reasons were allowed to be enrolled in this study. Patients who had previously received anlotinib were excluded from the study).
  • Anti-tumor treatments such as radiotherapy, chemotherapy, immunotherapy and targeted therapy were used within 28 days before the first treatment.
Show all 30Show fewer
  • Allergic or contraindicated to any component or vehicle of the test drug.
  • Treatment with an investigational agent/instrument within 28 days prior to first dose.
  • Prior major surgery or trauma within 28 days prior to first dose and/or presence of any non-healing wound, fracture, or ulcer during the screening period.
  • Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1(except alopecia) during the screening period.
  • Uncontrolled or significant cardiovascular disease, including:
  • New York Heart Association (NYHA) class II or higher congestive heart failure, unstable angina pectoris, myocardial infarction occurred within 6 months before the first dose, or an arrhythmia requiring treatment during the screening period with a left ventricular ejection fraction (LVEF) of <50%.
  • Primary cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy).
  • Clinically significant history of QTc interval prolongation, or screening QTc interval >470ms for women and >450ms for men.
  • Symptomatic coronary heart disease requiring medical treatment during the screening period.
  • Records of concomitant use of ≥3 antihypertensive drug components within 14 days prior to the first dose, or systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg during the screening period (at rest, approximately 5 minutes apart, three consecutive measurements, averaged).
  • Previous hypertensive crisis or hypertensive encephalopathy.
  • Other condition investigator considered inappropriate.
  • Chest imaging during the screening period revealed interstitial lung disease or pulmonary fibrosis or pulmonary inflammation requiring treatment, or a history of pneumonia treated with oral or intravenous steroids within 6 months before the first dose.
  • Significant gastrointestinal abnormalities during the screening period that were judged by the investigator to be likely to interfere with drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, post-small bowel resection, etc.), or total gastrectomy, or a history of gastrointestinal perforation and/or fistula within 6 months prior to the first dose.
  • 24-hour urine protein quantitative examination must be performed when urine protein ≥2+ in routine urine examination during the screening period. Patients cannot be enrolled if quantitative urine protein ≥ 1g/24 h.
  • Active bleeding within 2 months before the first dose, or taking anticoagulants during the screening period (e.g., warfarin, phenprocoumon, and allow prophylactic use of low-dose aspirin and low-molecular weight heparin), Or investigator judged that there was a high risk of bleeding during the screening period (such as esophageal and gastric fundus varices with bleeding risk, locally active ulcer lesions, positive fecal occult blood could not exclude gastrointestinal bleeding, intermittent hemoptysis, etc.).
  • A history of deep vein thrombosis or pulmonary embolism or a thrombotic event such as a cerebrovascular accident within 6 months before the first dose (implantable venous port or catheter-derived thrombosis, investigator evaluation for enrollment).
  • Active infections that required systemic treatment during the screening period (oral, intravenous infusion).
  • HIV antibody positive during the screening period.
  • hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with virus replication, hepatitis C antibody (HCV-Ab) positive with virus replication during the screening period.
  • Any mental or cognitive impairment that may limit the understanding, execution, and adherence to the study.
  • Drug use and long-term alcohol abuse affected the evaluation of test results.
  • Pregnant or lactating women; Be unwilling or unable to during the treatment of this test and test the last 12 weeks after the treatment using effective methods of contraception among women of reproductive age [women of childbearing age include: did not receive any had menstruation and successful artificial sterilization (hysterectomy and bilateral tubal ligation or bilateral oophorectomy) or menstruating]; If the partner is a woman of childbearing age, the subject is a fertile man who is not using effective contraception.
  • Other conditions considered by the investigator to be inappropriate for trial participation, such as concomitant disease, concomitant therapy, or any laboratory abnormality, may interfere with the evaluation of efficacy and safety results.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: An Open-label, Multicenter, Phase II Study of Chiauranib Capsule in Patients With Advanced or Unresectable Soft Tissue Sarcoma Previously Failed to Standard of Care Treatment

This is a Phase 2, single-arm, open-label study in patients with advanced or unresectable soft tissue sarcoma.

Read the detailed description

This single-arm, open-label, multiple-center clinical trial aims to study the efficacy and safety of chiauranib in the treatment of patients with advanced or unresectable soft tissue sarcoma, and to explore potential biomarkers associated with chiauranib, as well as their correlation and clinical benefits.

Being tested
Chiauranib
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChiauranibDrug

    Also called CS2164

    50mg, orally once daily

Study groups in NCT05497843
Study groupRoleWhat they receive
Chiauranib capsuleExperimentalPatients take chiauranib capsules 50mg, orally once daily, 21 days as a cycle until objective disease progression
Receives: Drug: Chiauranib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival of 12 weeks(PFS12w)

    Proportion of subjects who did not have disease progression or recurrence (according to RECIST1.1) or death from any cause at week 12 after receiving medical treatment

    Measured: 12 weeks after the first dose

Secondary outcomes (6)

  1. Overall response rate (ORR)

    Proportion of participants who have a partial response (PR) or complete response (CR) to therapy according to RECIST 1.1

    Measured: Up to 2 years

  2. Progression-free survival (PFS)

    From the first time of treatment until the date of first documented progression or date of death from any cause, whichever comes first

    Measured: Up to 2 years

  3. Duration of response (DOR)

    From the first date of response until the date of first documented progression

    Measured: Up to 2 years

  4. Disease control rate (DCR)

    Proportion of participants in partial, complete or stable disease according to RECIST 1.1.

    Measured: Up to 2 years

  5. Overall survival (OS)

    From the first dose of treatment until the date of death from any cause

    Measured: Up to 2 years

  6. Safety and Tolerability

    Incidence of adverse events (AEs) as assessed by CTCAE 5.0

    Measured: Up to 28 days after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2022
  2. Study start25 Aug 2022
  3. Primary completion3 Jan 2025
  4. Study completion3 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05497843
Sponsor's protocol ID
CAR204
Status last verified
Mar 2025
First submitted
9 Aug 2022
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chiauranib in people with Soft Tissue Sarcoma, run by Chipscreen Biosciences, Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival of 12 weeks(PFS12w) (time frame: 12 weeks after the first dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05497843.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT05497843 | AzTrials