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PraG With RANKL Inhibitor for the Treatment of Advanced Multiple Metastatic Solid Tumors

NCT05435768 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 51

Last updated 2022-08-18

No results posted yet for this study

Summary

The PraG treatment model has synergistic effects with RANKL inhibitor therapy, and the combination of the two treatments provides a survival benefit for patients with multiple bone metastatic solid tumors who have failed first-line systemic therapy. Phase I clinical trial is planned to determine the safety of PraG treatment mode combined with RANKL inhibitor desomumab and the optimal treatment sequence and mode. Further phase II clinical trial was conducted to confirm the efficacy of PraG treatment combined with desomumab. The mechanism of combination therapy was analyzed and biomolecular markers for potential efficacy prediction were screened by detection of lymphocyte subsets, cytokines and metabolomics in peripheral blood.

Conditions

  • Metastatic Solid Tumor

Interventions

DRUG

Denosumab

Denosumab 120mg was subcutaneously administered one day before the commencement of radiotherapy or after the PraG treatment every 28 days

Sponsors & Collaborators

  • Second Affiliated Hospital of Soochow University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-16
Primary Completion
2024-08-15
Completion
2025-08-15

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05435768 on ClinicalTrials.gov