Personalized Long-course Radiotherapy Plus Chemotherapy With or Without Immunotherapy for LARC: PALACE Study

PHASE3RecruitingINTERVENTIONAL
Enrollment

184

Participants

Timeline

Start Date

November 19, 2024

Primary Completion Date

July 31, 2027

Study Completion Date

January 31, 2028

Conditions
Locally Advanced Rectal Cancer (LARC)ImmunotherapyRadiotherapyTotal Neoadjuvant TherapyAnal Function Preservation
Interventions
DRUG

Anti-PD-1 antibody drug named Serplulimab

Serplulimab

RADIATION

Radiotherapy

Radiotherapy is delivered using intensity-modulated radiotherapy (IMRT/VMAT) at a dose of 50-50.4Gy/ 25-28f(1.8-2.0Gy/d, 5f/w). For patients in the experimental group who achieve partial remission (PR) or better during the induction phase, an additional local boost dose of 6Gy/3f(2.0Gy/d, 5f/w) is administered to the PGTV.(No PGTV dose was given in the control group). For the treatment of lymph node metastasis in the lateral pelvic wall outside the mesorectal area: no additional dose is required when surgery is feasible, a sequential boost dose of 15Gy/3f is added when the lymph nodes are not surgically resectable.

DRUG

Chemotherapy

Capox

Trial Locations (1)

610041

RECRUITING

West China Hospital, Chengdu

All Listed Sponsors
lead

West China Hospital

OTHER