Short-course Radiotherapy Followed by Sequential Chemotherapy With or Without PD-1 Monoclonal Antibody and Bevacizumab as Total Neoadjuvant Therapy in pMMR/MSS Locally Advanced Rectal Cancer (SPARK)

PHASE2RecruitingINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

July 1, 2027

Study Completion Date

December 1, 2027

Conditions
pMMR/MSS Locally Advanced Rectal Cancer
Interventions
OTHER

Short-course radiotherapy followed by sequential chemotherapy combined with PD-1 monoclonal antibody and bevacizumab

Short-course radiotherapy → PD-1 monoclonal antibody and bevacizumab combined with CAPOX regimen chemotherapy (4 cycles) → PD-1 monoclonal antibody combined with CAPOX regimen chemotherapy (2 cycles) → undergo surgery or watch-and-wait strategy within 2-4 weeks after the last dose of capecitabine.

OTHER

Short-course radiotherapy followed by sequential chemotherapy

Short-course radiotherapy → CAPOX regimen chemotherapy (6 cycles) → undergo surgery or watch-and-wait strategy within 2-4 weeks after the last dose of capecitabine.

Trial Locations (1)

610655

RECRUITING

Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou

All Listed Sponsors
lead

Dechang Diao

OTHER