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Recruiting Phase 3 NCT06658353

NCT06658353 Phase III Clinical Study of VC004 in Patients With Localized Advanced/ Metastatic Solid Tumors

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Clinical Trial Summary
NCT ID NCT06658353
Status Recruiting
Phase Phase 3
Sponsor Jiangsu vcare pharmaceutical technology co., LTD
Condition Locally Advanced Solid Tumor
Study Type INTERVENTIONAL
Enrollment 54 participants
Start Date 2025-03-17
Primary Completion 2026-12-30

Eligibility & Interventions

Sex All sexes
Min Age 12 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
VC004 Capsules

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 54 participants in total. It began in 2025-03-17 with a primary completion date of 2026-12-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

This Study is a single arm, open label, multicenter phase III clinical trial to evaluate the safety and efficacy of VC004 in patients with locally advanced/metastatic solid tumors.

Eligibility Criteria

Inclusion Criteria: * All subjects or legal representatives are willing and able to sign ICF approved by the ethics committee before starting any screening procedures; * Male or female, age ≥12 years old; Exclusion Criteria: * Patients have undergone major surgery within 4 weeks prior to the first dose or are expected to undergo major surgery during the trial (excluding vascular access establishment procedures, biopsy procedures); * Adverse reactions caused by previous treatment have not recovered to ≤1 grade (evaluated by the investigator); * Patients had been treated with a strong CYP3A inhibitor or inducer within 7 days prior to the first administration of the study drug.

Contact & Investigator

Central Contact

xiaojuan Lai

✉ lai_xiaojuan@vcarepharmatech.com

📞 15358160458

Principal Investigator

yuankai Shi

PRINCIPAL INVESTIGATOR

Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College

Frequently Asked Questions

Who can join the NCT06658353 clinical trial?

This trial is open to participants of all sexes, aged 12 Years or older, studying Locally Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT06658353 trial and what does that mean for participants?

Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 54 participants.

Is NCT06658353 currently recruiting?

Yes, NCT06658353 is actively recruiting participants. Contact the research team at lai_xiaojuan@vcarepharmatech.com for enrollment information.

Where is the NCT06658353 trial being conducted?

This trial is being conducted at Beijing, China.

Who is sponsoring the NCT06658353 clinical trial?

NCT06658353 is sponsored by Jiangsu vcare pharmaceutical technology co., LTD. The principal investigator is yuankai Shi at Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College. The trial plans to enroll 54 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology