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Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 80

Tafolecimab with chemoimmunotherapy as neoadjuvant treatment for locally advanced colon cancer

Official title: 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)

Run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · NCT07840677 · Data updated 2026-11-12

This study tests whether adding tafolecimab to a chemoimmunotherapy regimen helps shrink locally advanced colon cancer before surgery in adults who have pMMR/MSS tumors.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment70 (estimated)
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University
Academic / other
Drugs / interventionschemotherapy, tolecizumab, sintilimab
Locations1 site (Chongqing, Chongqing Municipality)
StatusRecruiting
StartedSeptember 20, 2026
Main results expectedSeptember 20, 2029
Study endsSeptember 20, 2029
Registry record updatedSeptember 25, 2026
Trial IDNCT07840677 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18-80 with newly diagnosed, resectable locally advanced colon adenocarcinoma (cT3c or higher) and good organ function, who have not received prior anti-tumor therapy for the current cancer.

Probably not a fit

Patients with prior anti-tumor treatment for the current cancer, active autoimmune disease, or contraindications to PCSK9/PD-1 inhibitors may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, open-label Phase II trial evaluating tafolecimab, a PCSK9 inhibitor, plus sintilimab and CapeOX chemotherapy as a neoadjuvant approach for patients with pMMR/MSS locally advanced colon adenocarcinoma. Participants are adults 18-80 with ECOG 0-1 and no prior anti-cancer treatment for the current tumor. The study compares this combination to a control strategy to determine efficacy and safety, with endpoints focused on tumor response and surgical feasibility. The trial is conducted at Daping Hospital and collaborating centers in Chongqing, China, and follows standard safety monitoring and blinded-endpoint assessment where applicable.

Why it matters

Potential benefit: If successful, patients may have higher rates of tumor shrinkage before surgery and potentially improved long-term outcomes.

How similar studies have gone: Previous approaches using immunotherapy plus chemotherapy in rectal/colon cancer have shown activity, but this particular PCSK9 inhibition plus PD-1 blockade in the neoadjuvant setting is investigational.

Who can join: the full rules

Show full inclusion / exclusion 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.).

Where it's running

  • Daping Hospital Third Military Medical University
    Chongqing, Chongqing Municipality, China     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.