Clinical Trials Logo
  1. Home
  2. Locally Advanced Rectal Cancer
  3. NCT05980689

Combination of AK104 and Neoadjuvant Chemoradiotherapy in pMMR/MSS Locally Advanced Rectal Cancer

Locally Advanced Rectal Cancer Clinical Trial

Official title:
A Phase II Trial of AK104 Combined With Neoadjuvant Chemoradiotherapy in Proficient Mismatch Repair/Microsatellite Stable Locally Advanced Rectal Cancer

Clinical Trial Summary

This is an open-label, single-arm study to investigate the efficacy and safety of AK104 (an Anti-PD1 and Anti-CTLA4 Bispecific Antibody) and neoadjuvant chemoradiotherapy in patients with pMMR/MSS locally advanced rectal cancer.

Clinical Trial Description

The study evaluates the addition of AK104(an Anti-PD1 and Anti-CTLA4 Bispecific Antibody) in neoadjuvant chemoradiotherapy in proficient Mismatch Repair (pMMR) /Microsatellite Stable (MSS) locally advanced rectal cancer (LARC). A total of 33 pMMR/MSS LARC patients will receive long-course chemoradiotherapy plus 2 cycles of AK104, followed by another 3 cycles of AK104, finally received clinical routine manage. The tumor response to treatment, adverse effects and long-term prognosis will be analyzed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05980689
Study type Interventional
Source Sun Yat-sen University
Contact WeiWei Xiao
Phone 8613710390520
Email xiaoww@sysucc.org.cn
Status Recruiting
Phase Phase 2
Start date October 24, 2023
Completion date January 31, 2025
View Details
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 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
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