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Immunotherapy With Adaptive Pulse Radiotherapy in Solid Tumors

Study acronym: I-APT
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Enrollment increased: 35 → 45 participants
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 6 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to find out whether Adaptive Pulse Radiotherapy (Pulse RT) combined with immune checkpoint inhibitors (ICIs) helps treat advanced solid tumors. It will also check how safe this combined treatment is and how it affects the immune system and quality of life. The main questions the study will try to answer are: Does adding Pulse RT to ICIs improve tumor response and survival? What side effects occur when participants receive Pulse RT with ICIs? How does the treatment change immune-related blood and tissue markers? Does the treatment affect participants' quality of life? Researchers will compare this new approach to usual ICI treatment to see whether Pulse RT makes a difference. Participants will: Continue to receive their standard ICI treatment. Receive 2-3 sessions of high-dose Pulse RT (8-10 Gy each) given about every 3 weeks. Have the treatment volume adjusted based on how their tumors respond. Visit the clinic regularly for check-ups, imaging, blood tests, and quality-of-life questionnaires.
Trial Details
NCT Number NCT07381231
Lead Sponsor Samsung Medical Center
Conditions
(from sponsor)		 Cancer
Related terms Neoplasms
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov