Assessment of Efficacy and Safety of PD-1 Monoclonal Antibody Combined With IL-2 and CapeOX in Neoadjuvant Therapy for Locally Advanced Rectal Cancer Prior to Surgery: A Prospective, Multi-center, Randomized Controlled Study

PHASE2RecruitingINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

March 18, 2025

Primary Completion Date

December 10, 2025

Study Completion Date

July 10, 2027

Conditions
Rectal Cancer
Interventions
DRUG

Interleukin-2

Tislelizumab 200mg ivd D1+Interleukin 2 100IU HD, d1-d14+ CapeOX (Capecitabine: 825mg/m2 bid po, d1-d14;Oxaliplatin 200 mg/m² ivd, d1)

RADIATION

Radiotherapy

Radiotherapy 1.8Gy per time\*28

DRUG

Tislelizumab

Tislelizumab 200mg ivd D1

DRUG

Oxaliplatin

Oxaliplatin 200 mg/m² ivd, d1

DRUG

Capecitabine

Capecitabine: 825mg/m2 bid po, d1-d14

Trial Locations (4)

210000

RECRUITING

Nanjing BenQ Hospital, Nanjing

210029

RECRUITING

Jiangsu province hospital, Nanjing

Unknown

RECRUITING

Xuzhou Central hospital, Xuzhou

RECRUITING

The Affiliated Hospital of Jiangsu University, Zhenjiang

All Listed Sponsors
lead

The First Affiliated Hospital with Nanjing Medical University

OTHER