Clinical Trials Logo

Clinical Trial Summary

This study is a single-center, prospective, open-label, randomized controlled clinical study, and the purpose of this study was to compare the pathological complete response rate (PCR) of patients with locally advanced rectal cancer treated with short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A) versus short-course radiotherapy sequential CapeOX (group B). A total of 100 patients with locally advanced rectal cancer will be enrolled in the study. These patients were randomly assigned to the experimental group (group A) and the control group (group B) in a ratio of 1:1.


Clinical Trial Description

Baseline examnation: All enrolled patients in this study, in addition to routine laboratory and imaging examinations such as blood routine, blood biochemistry, serum tumor markers (Incl. CEA, CA-199, CA-724 β2-microglobulin, Ferroprotein), chest CT, abdominal and pelvic MRI, etc., were required to undergo KRAS, NRAS, BREF, PD-L1, MMR/MSS testings before SCRT, and blood lymphocyte subgroups were analyzed before SCRT, systemic therapy, and surgery. Subjects in group A will be treated according to the following treatment plan: Standard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5) Sequential treatment period: After resting for 3-7 days following completion of SCRT, patients were treated with 4 cycles of CapeOX (Oxaliplatin 130 mg/m2 intravenously, day 1; Capecitabine 1000 mg/m2, Bid,days 1-14) and an additional intravenous infusion of 200mg Tislelizumab on the first day of each cycle of CapeOX. Surgery: After 3 weeks of the completion of neoadjuvant therapy, the TME surgery was performed. Postoperative adjuvant chemotherapy:Whether postoperative chemotherapy was implemented mainly depended on the patient's wishes, and 2 cycles of CapeOX with or without Tislelizumab will be undergone to these willing cases. Subjects in group B will be treated according to the following treatment plan: Standard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5) Sequential treatment period: After resting for 3-7 days following completion of SCRT, patients were treated with 4 cycles of CapeOX (Oxaliplatin 130 mg/m2 intravenously, day 1; Capecitabine 1000 mg/m2, Bid,days 1-14). Surgery: After 3 weeks of the completion of neoadjuvant therapy, the TME surgery was performed. Postoperative adjuvant chemotherapy:Whether postoperative chemotherapy was implemented mainly depended on the patient's wishes, and 2 cycles of CapeOX will be undergone to these willing cases. Endpoint: The primary endpoint was pCR rate. Secondary endpoints included MPR (TRG0+TRG1), 3-year PFS, 3-year OS, and treatment safety. Follow-up records during treatment: For the duration of operation, the time required to complete the TME surgery and the amount of blood loss were recorded, and the impact of neoadjuvant therapy on the operation was observed. During the SCRT process, and the period of resting after SCRT, of the entire preoperative systemic treatment, of the resting after TME surgery, of the postoperative chemotherapy (these willing cases), the occurrence of adverse events (AE) of participants were closely monitored and actively responded. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05086627
Study type Interventional
Source Hebei Medical University Fourth Hospital
Contact Linlin Xiao, MD
Phone 0311-86095361
Email drxiaolinlin@163.com
Status Recruiting
Phase Phase 2
Start date October 15, 2022
Completion date May 15, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT05079438 - Dendrobium Huoshanense Suppository in Rectal Cancer Phase 3
Recruiting NCT02964468 - Dose-escalation Trial of Preoperative Radiotherapy and Concurrent Chemotherapy in Locally Advanced Rectal Cancer N/A
Not yet recruiting NCT05507112 - TIME in Immunotherapy Combined With nCRT for Rectal Cancer Phase 2
Not yet recruiting NCT05998122 - Total Neoadjuvant Chemoradiotherapy Plus Anti-PD-1 in Subperitoneal Patients With Locally Advanced Rectal CancerPatients With Locally Advanced Rectal Cancer: A Prospective, Single Arm, Exploratory Study Phase 2
Completed NCT04324567 - Inflammation After Laparoscopic Robot-assisted Surgery for Locally Advanced Rectal Cancer
Recruiting NCT05412082 - SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer Phase 1
Recruiting NCT05980689 - Combination of AK104 and Neoadjuvant Chemoradiotherapy in pMMR/MSS Locally Advanced Rectal Cancer Phase 2
Recruiting NCT02605265 - Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1 Phase 3
Terminated NCT02151019 - Pre-operative 3-DCRT vs IMRT for Locally Advanced Rectal Cancer Phase 1/Phase 2
Not yet recruiting NCT05076305 - PelvEx 4: Advanced Pelvic Malignancy and the Role of the Multi-disciplinary Team Meeting
Recruiting NCT03824899 - UGT1A1 Combined With Pharmacokinetics of SN-38 in CPT-11-based CRT in Patients With Advanced Rectal Cancer N/A
Recruiting NCT05845268 - Total Neoadjuvant Therapy Combined With Tislelizumab for Local Advanced of Middle and Low Rectal Cancer Phase 2
Completed NCT03392584 - Detection and Inflammatory Characterization of Deep Infection After Surgery for Locally Advanced Rectal Cancer With Microdialysis Catheters
Terminated NCT04177602 - Evaluating Trifluridine/Tipiracil Based Chemoradiation in Locally Advanced Rectal Cancer - The Phase I/II TARC Trial Phase 1/Phase 2
Recruiting NCT05646511 - Total Neoadjuvant Therapy of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer (ENSEMBLE) Phase 3
Terminated NCT02290574 - Efficacy of NeoThermo-Radio-chemotherapy for LA Rectal Cancer Before Laparoscopic TME: Prospective Phase II Trial N/A
Recruiting NCT03702985 - Radiation-protection Effect of Amifostine in Locally Advanced Rectal Cancer Phase 2
Active, not recruiting NCT05877352 - Intraoperative Electron Radiotherapy in Rectal Cancer - A Feasibility Trial N/A
Not yet recruiting NCT06375434 - Correlation Between Gut Microbiota and Radiosensitivity of Rectal Cancer
Recruiting NCT04423965 - A Trial of Neoadjuvant mFOLFOXIRI Versus CRT in the EMVI Positive LARC Phase 2