Daping Hospital Third Military Medical University
Chongqing, Chongqing Municipality, 400000, China
Location status: Recruiting
NCT Number: NCT07840677
This multicenter, randomized, open-label, blinded-endpoint Phase II trial assesses the efficacy and safety of tolecizumab (PCSK9 inhibitor) plus sintilimab/CapeOX chemoimmunotherapy as neoadjuvant treatment for pMMR/MSS locally advanced colon adenocarcinoma .
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 2
Chongqing, Chongqing Municipality, 400000, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tolecizumab (PCSK9 Inhibitor) 600mg, subcutaneous injection, Q6W (Weeks 1,7), 2 doses total Sintilimab (PD-1 Inhibitor) 200mg, intravenous infusion, Q3W (Weeks1,4,7,10), 4 cycles total CapeOX Regimen (Oxaliplatin + Capecitabine) Oxaliplatin 130mg/m² IV Q3W (4 cycles); Capecitabine 1000mg/m² oral twice daily, Days1-14 per cycle
Time frame: The pCR rate will be evaluated after surgery, an average of 12 weeks
pCR was defined as the absence, from surgical samples, of malignant cells in the primary site and regional lymph nodes
Time frame: MPR rate assessed postoperatively, at an average of 12 weeks
MPR is defined as ≤10% residual viable tumor cells in the primary tumor bed of the surgical specimen following neoadjuvant therapy
Time frame: 3 years
Defined as the time from randomization to relapse or death, whichever occurred first.
Time frame: 3 years
Defined as the time from randomization to date of death due to any cause according to RECIST version 1.1 recorded in the time period between randomization and disease
Time frame: From enrollment to 12 Weeks of treatment end
Down-staging of the resected tumour as measured by histopathological tumour diameter and stage according to the TNM staging system of AJCC (9th version).
Time frame: Surgical operation assessment
Curative resection defined as complete tumor resection with all margins being negative.
Time frame: After 4 cycles of neoadjuvant therapy (10 weeks)
Objective response is defined as a complete response (CR) or response (PR) according to RECIST v1.1
Time frame: From enrollment to 12 Weeks of treatment end
Interested in participating?
Request InfoDaping Hospital and the Research Institute of Surgery of the Third Military Medical University
Other
A Multicenter, Randomized, Two-arm, Open-label, Blinded Endpoint, Phase II Study of PCSK9 Inhibitor Tafolecimab Combined With Sintilimab and CapeOX Chemotherapy as Neoadjuvant Treatment for pMMR/MSS Locally Advanced Colon Cancer (TRIUNITE-08)
Acronym: TRIUNITE-08
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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