Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma (TRIUNITE-08)

March 9, 2026 updated by: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

A Multicenter, Randomized, Open-Label, Blinded-Endpoint Phase II Study of Tolecizumab (a PCSK9 Inhibitor) Enhancing Chemoimmunotherapy as Neoadjuvant Treatment for Patients With pMMR/MSS Locally Advanced Colon Adenocarcinoma (TRIUNITE-08)

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 (cT3c+). 106 patients are 1:1 randomized to the combination or chemoimmunotherapy alone, with pCR as the primary endpoint.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, randomized, open-label, blinded-endpoint Phase II clinical trial designed to evaluate the efficacy and safety of tolecizumab (a PCSK9 inhibitor) combined with chemoimmunotherapy (sintilimab plus CapeOX regimen) as neoadjuvant treatment for patients with pMMR/MSS locally advanced colon adenocarcinoma (cT3c stage or above). A total of 106 eligible patients will be randomized 1:1 into two arms: Arm A (tolecizumab + sintilimab + CapeOX) and Arm B (sintilimab + CapeOX), both receiving 4 cycles of neoadjuvant therapy. The primary endpoint is the pathological complete response rate (pCR) after treatment; secondary endpoints include major pathological response rate (MPR), objective response rate (ORR), R0 resection rate, progression-free survival (PFS), overall survival (OS), and the incidence of adverse events (AEs) graded by NCI-CTCAE V5.0. A virtual historical control (single-agent CapeOX neoadjuvant chemotherapy) is set only for sample size calculation. The study will conduct safety follow-up for up to 90 days after the last administration and survival follow-up every 3 months for a total of 3 years, and also collect biological samples for exploratory biomarker analysis to explore the predictive factors of treatment efficacy. All study drugs and related examinations are provided free of charge for participants, and a Data and Safety Monitoring Board (DSMB) is established to monitor the study process and ensure participant safety.

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • Daping Hospital Third Military Medical University, chongqing, chongqing 400000 Recruiting
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed the written informed consent form and voluntarily participate in the study.

Pathohistologically confirmed colon adenocarcinoma with cT3c stage or above. Aged 18 to 80 years, regardless of gender. The lower edge of the tumor is more than 10 cm from the anus. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Sufficient bone marrow, liver, kidney and coagulation functions assessed by laboratory tests (in accordance with the local laboratory reference range).

No previous anti-tumor treatment for the current colon cancer (including radiotherapy, chemotherapy, surgery, etc.).

No pregnancy or lactation for female patients; male patients agree to take effective contraceptive measures during the study.

Exclusion Criteria:

  • Previous anti-tumor treatment for the current colon cancer. Previous use of PCSK9 inhibitors or PD-1/PD-L1 inhibitors. Active autoimmune diseases or a history of autoimmune diseases. Receiving immunosuppressant or systemic glucocorticoid therapy (except for local low-dose glucocorticoid use).

Active infection requiring systemic anti-infective treatment. Severe cardiovascular diseases (e.g., severe hypertension, myocardial infarction, heart failure, etc.).

Complicated primary tumor (e.g., tumor perforation, intestinal obstruction without relief after intervention).

Pregnant or lactating women. Other conditions that the investigator deems unfit for participation in the study (e.g., poor compliance, severe organ dysfunction, etc.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1.Monoclonal Antibody 2. Immunotherapy 3. Chemotherapy
  1. Tolecizumab (PCSK9 inhibitor) 600mg, subcutaneous injection, Q6W (Weeks 1,7), total 2 doses
  2. Sintilimab (PD-1 inhibitor) 200mg, intravenous infusion, Q3W (Weeks1,4,7,10), total 4 cycles
  3. CapeOX regimen (Oxaliplatin + Capecitabine) Oxaliplatin 130mg/m², IV infusion Q3W (4 cycles); Capecitabine 1000mg/m², oral twice daily, Days1-14 per cycle
Drug: Tolecizumab (PCSK9 Inhibitor)
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
Other Names:
  • Sintilimab (PD-1 Inhibitor)
  • CapeOX Regimen (Oxaliplatin + Capecitabine)
Drug: Sintilimab
  1. Oxaliplatin: 130mg/m² intravenous infusion, Q3W at Week 1,4,7,10, total 4 cycles; 2. Capecitabine: 1000mg/m² oral administration, twice daily, Days 1-14 of each chemotherapy cycle. All drugs free of charge.
  2. Sintilimab 200mg intravenous infusion, administered every 3 weeks (Q3W) at Week 1, 4, 7, 10, total 4 cycles; provided free of charge by the sponsor, used for neoadjuvant immunotherapy.
Other Names:
  • CapeOX
Experimental: 1. Immunotherapy 2. Chemotherapy
  1. Sintilimab (PD-1 inhibitor) 200mg, intravenous infusion, Q3W (Weeks1,4,7,10), total 4
  2. CapeOX regimen (Oxaliplatin + Capecitabine) Oxaliplatin 130mg/m², IV infusion Q3W (4 cycles); Capecitabine 1000mg/m², oral twice daily, Days1-14 per cycle
Drug: Sintilimab
  1. Oxaliplatin: 130mg/m² intravenous infusion, Q3W at Week 1,4,7,10, total 4 cycles; 2. Capecitabine: 1000mg/m² oral administration, twice daily, Days 1-14 of each chemotherapy cycle. All drugs free of charge.
  2. Sintilimab 200mg intravenous infusion, administered every 3 weeks (Q3W) at Week 1, 4, 7, 10, total 4 cycles; provided free of charge by the sponsor, used for neoadjuvant immunotherapy.
Other Names:
  • CapeOX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pCR
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
The pCR rate will be evaluated after surgery, an average of 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 3 years
Defined as the time from randomization to relapse or death, whichever occurred first.
3 years
Overall survival (OS)
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 progression or death to any cause
3 years
MPR
Time Frame: From enrollment to 12 Weeks of treatment end
After neoadjuvant therapy, the percentage of residual viable tumor cells in the tumor bed ≤ 10%. Regardless of whether there are viable tumor cells left in the lymph nodes
From enrollment to 12 Weeks of treatment end
Curative resection
Time Frame: Surgical operation assessment
Curative resection defined as complete tumor resection with all margins being negative.
Surgical operation assessment
Primary tumor downstaging rate
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).
From enrollment to 12 Weeks of treatment end
Objective Response Rate (ORR)
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
After 4 cycles of neoadjuvant therapy (10 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Collaborators

Southwest Hospital, China
Chongqing Shapingba District People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 10, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIUNITE-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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