A Phase II Clinical Study Evaluating the Effectiveness of Injectable NC527-X in Intraoperative Imaging for Patients With Solid Tumors

ConditionCancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang Cancer Hospital

About this trial

Evaluate the initial dose-effect and time-effect relationship of the injection product NC527-X

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Voluntarily sign a written informed consent form;

2. Male and female individuals aged 18 years or above;

3. Patients with solid tumors that have been diagnosed by imaging tests or confirmed by pathology and who are scheduled for surgical removal;

4. The ECOG score ranges from 0 to 1;

Disqualifiers

1. Has a history of allergic reactions to similar products, contrast agents, or fluorescent lamps, or is known to be allergic to the study drug or any other components.

2. 28 days prior to the first administration, the subject had received a similar drug (such as indocyanine green for injection);

3. Within one month prior to the first administration, participants were enrolled in another clinical study (including observational or non-interventional clinical studies);

4. Within 28 days prior to the first administration, had received a live attenuated vaccine;

Trial design

Design model

Single group

Treatments tested in this trial

  • Experimental:Preoperative injection of NC527-X

    Drug

    This study will set up four single-arm dose groups (A, B, C, D), and it will be conducted in patients with solid tumors who have been diagnosed and are scheduled for surgical resection (evaluated by the researchers to have no surgical contraindications). The study will initially assign patients to groups A, B, C, and D respectively, with each group planning to include at least 3 cases, and a total of no more than 100 cases will be enrolled. The dosages will be 0.005 mg/kg, 0.01 mg/kg, 0.02 mg/kg, and 0.04 mg/kg, and the imaging time window after administration will be 24 to 72 hours.

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Experimental:Preoperative injection of NC527-XExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Signal-to-Background Ratio (SBR)

Signal-to-Background Ratio (SBR): The ratio of the average signal intensity of the target area (tumor) to the average signal intensity of the background tissue.

Time frame
From the 1st to the 3rd day after administration

Secondary outcomes

Other outcomes

Sponsors and contacts

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