Actively Recruiting

Phase 2
Age: 2Years - 70Years
All Genders
NCT05926492

A Clinical Study of Surufatinib Combined With Chemotherapy as Neoadjuvant Treatment in Osteosarcoma

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-04-17

160

Participants Needed

1

Research Sites

129 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This phase II study aims to explore the tumor necrosis rate in osteosarcoma patients treated with a neoadjuvant regimen of surufatinib combined with chemotherapy.

CONDITIONS

Official Title

A Clinical Study of Surufatinib Combined With Chemotherapy as Neoadjuvant Treatment in Osteosarcoma

Who Can Participate

Age: 2Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Understand and voluntarily sign informed consent
  • Age between 2 and 70 years old, any gender
  • Histological or cytological confirmation of primary bone tumor
  • At least one measurable lesion by RECIST 1.1
  • No prior treatment including chemotherapy, targeted, or immune therapies
  • Normal major organ and bone marrow function
  • ECOG performance status 0 or 1 (0-2 for amputees)
  • Expected survival of at least 12 weeks
  • Blood tests within specified ranges for neutrophils, platelets, hemoglobin
  • Liver function tests within limits (adjusted for liver metastasis)
  • Renal function with serum creatinine and creatinine clearance within limits
  • Use of effective contraceptive methods during study and 6 months after
  • Female patients considered fertile unless menopausal, sterilized, or otherwise documented
Not Eligible

You will not qualify if you...

  • Previous chemotherapy, surufatinib, or antiangiogenic therapy
  • Systemic anti-tumor therapy within 4 weeks before enrollment
  • Surgery or invasive procedures within 4 weeks before enrollment (except minor procedures)
  • INR greater than 1.5 or APTT greater than 1.5 times normal
  • Clinically significant electrolyte abnormalities
  • Uncontrolled hypertension with systolic ≥140 mmHg or diastolic ≥90 mmHg
  • Poor blood glucose control (FBG >10 mmol/L)
  • Conditions affecting drug absorption or inability to take surufatinib orally
  • Active gastrointestinal diseases that may cause bleeding or perforation
  • Significant bleeding history or thromboembolic events within specified times
  • Significant cardiovascular disease including recent heart attack, unstable angina, heart failure NYHA class >2, arrhythmias requiring treatment, or low left ventricular ejection fraction (<50%)
  • Other malignancies within 5 years except certain skin or cervical cancers
  • Active or uncontrolled severe infections including HIV, active hepatitis B or C, cirrhosis
  • Current or previous central nervous system metastases
  • Persistent toxicity from prior therapy not resolved to grade 2 or less (except alopecia or lymphocytopenia)
  • Pregnant or breastfeeding women
  • Recent blood transfusions or hematopoietic factor use within 14 days
  • Any other medical or laboratory abnormalities judged unsuitable by investigator
  • Urine protein ≥2+ or 24-hour urinary protein >1.0 g

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Actively Recruiting

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Research Team

B

Binghao Li, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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