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NCT07840677From ClinicalTrials.govRecruiting

Tafolecimab Combined With Chemoimmunotherapy as Neoadjuvant Treatment for pMMR/MSS Locally Advanced Colon Cancer

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)

  • Colon Cancer
  • PCSK9 Inhibitor
  • Neoadjuvant Immunochemotherapy

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Enrolment target
70
Started
20 September 2026
Main results due
20 September 2029
Study sites
1
Registry updated
25 September 2026

Can you take part?

  • Ages 18 years to 80 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.).
* Fasting LDL-C \<1.0 mmol/L (39 mg/dL), only excluding extremely low levels (suggestive of cachexia/severe hepatic disease)
* 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.).

What this study is about

In the sponsor’s own words, from the registry.

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 .

Study sites(1)

  • Daping Hospital Third Military Medical University

    Chongqing, Chongqing Municipality, China

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07840677. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Tafolecimab Combined With Chemoimmunotherapy as Neoadjuvant Treatment for pMMR/MSS Locally Advanced Colon Canc | Trialion