Clinical Research Directory
Browse clinical research sites, groups, and studies.
SBRT + PD-1 Antibody in Unresectable Locally Recurrent Rectal Cancer(SPARKLE)
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Summary
This is a prospective study to delve into the therapeutic benefits of combining stereotactic body radiation therapy (SBRT) with PD-1 monoclonal antibody treatment for patients with unresectable locally recurrent rectal cancer (ULRRC). Our aim is to ascertain the safety of this approach and to offer robust, evidence-based medical guidance for the management of ULRRC using this innovative combination therapy. Researchers will combine SBRT with PD-1 for ULRRC to see if this treatment can provide a benefit of survival. Participants will: 1. Receive chemotherapy combined with PD-1 therapy for 1 cycle → SBRT treatment → Chemotherapy combined with PD-1 therapy for 3-6 cycles (assessment 6 weeks after SBRT treatment) → Surgery/Maintenance therapy. 2. Visit the clinic once every 3 months for checkups and tests
Official title: Evaluation of the Efficiency and Safety of Stereotactic Body Radiation Therapy Combined With PD-1 Antibody in the Treatment of Unresectable Locally Recurrent Rectal Cancer: A Prospective, Multicenter, Single-Arm, Open Label, Phase II Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
31
Start Date
2025-01-06
Completion Date
2027-11-30
Last Updated
2025-01-22
Healthy Volunteers
No
Interventions
Stereotactic Body Radiation Therapy (SBRT)
Patients will begin SBRT treatment within 2 weeks after the first round of chemotherapy. Intensity-modulated radiation therapy (IMRT) technology will be used, with a target gross tumor volume (GTV) of 5-8Gy/5 sessions, a total dose of 25-40Gy equivalent to a biological effective dose (BED) of 37.5-72Gy, administered from Monday to Friday. For patients who have previously received pelvic radiotherapy, the re-irradiation dose will be 3-5Gy/5 sessions, a total dose of 15-25Gy equivalent to a BED of 19.5-37.5Gy, administered from Monday to Friday.
PD1
The PD-1 monoclonal antibody used is Sintilimab 200mg every 3 weeks
Chemotherapy
First-line chemotherapy regimen of rectal cancer, using a second-line regimen primarily based on fluorouracil, such as a tri-weekly CAPOX or a bi-weekly mFOLFOX6/FOLFIRI/FOLFOXIRI + targeted therapy
Locations (1)
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China