Actively Recruiting
Apatinib Mesylate Versus Standard Second-line TKI in the Treatment of Advanced Gastrointestinal Stromal Tumors: a Randomized, Open, Controlled, Single-center Clinical Study
Led by Xiangya Hospital of Central South University · Updated on 2023-03-02
258
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
X
Xiangya Hospital of Central South University
Lead Sponsor
S
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of Apatinib Mesylate compared with standard second-line tyrosine kinase inhibitors (TKIs) in patients with advanced gastrointestinal stromal tumors (GIST) who have experienced failure with first-line TKI treatment. It also explores how the expression of VEGFR2 and microvessel density (MVD) relate to tumor characteristics such as location, size, mitotic count, and recurrence risk. The study is a randomized, open, controlled, single-center clinical trial involving patients with advanced GIST. Participants are randomly assigned in a 1:1 ratio to receive either Apatinib Mesylate, a new small molecule anti-angiogenic drug targeting VEGFR2, C-Kit, and PDGFR, or standard second-line TKI therapies such as Sunitinib, Imatinib, Dasatinib, or Reveratinib. The study focuses on comparing these two treatment groups to assess their outcomes. During the trial, participants are monitored for progression-free survival over 12 months, with additional evaluations of overall survival, objective response rate, and disease control rate over 24 months. Genetic testing involving blood samples and tumor tissue analysis is conducted when available. Safety and treatment response are closely observed, and participants are followed for at least two years to assess treatment impact and tumor control.
CONDITIONS
Brief Title
Apatinib Mesylate Versus Standard Second-line TKI in the Treatment of Advanced GIST
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily enrolled with signed informed consent and good compliance
- Age 18 years or older, men and women
- Previous first-line TKI treatment (Imatinib or Avatinib) with treatment failure
- Willing to provide blood samples and tumor tissue for genetic testing
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1
- Predicted survival of at least 12 weeks
You will not qualify if you...
- Previous molecular targeted therapy other than Imatinib or Avatinib for GIST
- Unrecovered toxicity from prior Imatinib or Avatinib treatment above level 1 per NCICTCAE5.0
- Clinical symptoms of ascites or pleural effusion requiring drainage within 1 month before consent, except small asymptomatic cases
- Second primary cancer within 5 years, except adequately treated skin basal or squamous cell carcinoma or cervical carcinoma in situ
- GIST with central nervous system metastasis
- Inability to swallow, chronic diarrhea, or intestinal obstruction affecting drug administration or absorption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 months or until disease progression or discontinuation
Participants receive either Apatinib Mesylate or standard second-line TKI therapy as treatment for advanced gastrointestinal stromal tumors after first-line TKI failure.
Trial Site Locations
Total: 1 location
1
Xiangya Hospital, Central South University
Changsha, Hunan, China, 410013
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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