Clinical Trials Logo

Clinical Trial Summary

Previously, preliminary results, from a subgroup analysis of STARS-RC03 (NCT04906044) conducted by our research team, showed that the 6-cycles consolidation chemotherapy combining with anti-PD-1 therapy had a better tumor regression advantage with a restricted safety profile contrasted with 3-cycle counterparts. Herein, we designed this study to further evaluate the short-term efficacy (such as pCR rate, R0 resection rate, etc.) and long-term survival (including DFS, OS, etc.) of 6-cycles consolidation therapy.


Clinical Trial Description

The combination of total neoadjuvant treatment (TNT) and immunotherapy has shown a significant improvement in the pCR rate compared to the standard of care (SOC) or TNT alone for pMMR LARC. On this basis, we believe that this treatment mode will offers the opportunity of organ preservation for subperitoneal "Bad" or "Advanced" patients with LARC, who are initially assessed as unresectable or difficult to obtain R0 resection. Previously, preliminary results, from a subgroup analysis of STARS-RC03 (NCT04906044) conducted by our research team, showed that the 6-cycles consolidation chemotherapy combining with anti-PD-1 therapy had a better tumor regression advantage with a restricted safety profile contrasted with 3-cycle counterparts. Herein, we designed this study to further evaluate the short-term efficacy (such as pCR rate, R0 resection rate, etc.) and long-term survival (including DFS, OS, etc.) of 6-cycles consolidation therapy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05998122
Study type Interventional
Source The First Hospital of Jilin University
Contact Wang Quan, Prof.
Phone +86-431-81875602
Email wquan@jlu.edu.cn
Status Not yet recruiting
Phase Phase 2
Start date September 1, 2023
Completion date December 31, 2028

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
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
Recruiting NCT05086627 - Short-course Radiotherapy Followed by Tislelizumab + CapeOX in the Treatment for Locally Advanced Rectal Cancer 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