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

PHASE2RecruitingINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

January 6, 2025

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2027

Conditions
Unresectable Locally Recurrent Rectal Cancer
Interventions
RADIATION

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.

DRUG

PD1

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

DRUG

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

Trial Locations (1)

510065

RECRUITING

Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou

All Listed Sponsors
collaborator

Fudan University

OTHER

collaborator

Sun Yat-sen University

OTHER

collaborator

Yunnan Cancer Hospital

OTHER

collaborator

Shenzhen People's Hospital

OTHER

lead

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER