Actively Recruiting
A Phase II Clinical Study Evaluating the Effectiveness of Injectable NC527-X in Intraoperative Imaging for Patients With Solid Tumors
Led by Zhejiang Cancer Hospital · Updated on 2026-04-20
400
Participants Needed
1
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate the initial dose-effect and time-effect relationship of the injection product NC527-X
CONDITIONS
Official Title
A Phase II Clinical Study Evaluating the Effectiveness of Injectable NC527-X in Intraoperative Imaging for Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign a written informed consent form
- Male or female aged 18 years or above
- Diagnosed with solid tumors by imaging or pathology and scheduled for surgical removal
- ECOG performance status score between 0 and 1
- Use effective contraception during the trial and for 3 months after completing medication
- Able to understand the study procedures and willing to follow the clinical trial protocol fully
You will not qualify if you...
- History of allergic reactions to similar products, contrast agents, fluorescent dyes, or study drug components
- Received a similar drug (e.g., indocyanine green injection) within 28 days before first administration
- Enrolled in another clinical study within one month prior to first administration
- Received a live attenuated vaccine within 28 days before first administration
- Underwent major surgery within one month before first administration
- Previous allogeneic stem cell or solid organ transplant
- Unrecovered adverse reactions from prior treatments above grade 1 according to CTCAE 5.0 within 28 days before first administration
- Poor organ function based on laboratory tests during screening, including blood, liver, kidney, and coagulation abnormalities
- Primary central nervous system tumors or symptomatic central nervous system metastases
- Cardiovascular diseases within 6 months before first administration, including symptomatic heart failure (NYHA 2 or above), LVEF <50%, unstable arrhythmia or angina, myocardial infarction, pulmonary embolism, uncontrolled hypertension, or prolonged QTc on ECG
- Severe or active infection within 4 weeks or 2 weeks prior to first administration respectively
- Infection with HIV, active hepatitis B or C virus, or positive syphilis tests
- Pregnancy, breastfeeding, or plans for pregnancy within study duration
- Any other medical conditions or abnormalities judged by investigators to contraindicate study drug use or affect results or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
X
Xiangdong Cheng Cheng
CONTACT
C
Can Hu Hu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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