RecruitingPhase 2NCT06767007

SBRT + PD-1 Antibody in Unresectable Locally Recurrent Rectal Cancer(SPARKLE)

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


Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

31 participants

Start Date

Jan 6, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Chemotherapy, a drug called PD1, and others for people with unresectable locally recurrent rectal cancer. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic 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.

DRUGPD1

The PD-1 monoclonal antibody used is Sintilimab 200mg every 3 weeks

DRUGChemotherapy

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

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NCT06767007


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