NCT07840677RecruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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 .
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 19 Sept 2026
- Start date
- Sept 2026
- Primary completion date
- Sept 2029
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Diseases
- Colorectal cancer
- NCT number
- NCT07840677
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 70
- From Sept 2026 to the primary completion date, Sept 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous anti-tumor treatment for the current colon cancer.
- Previous use of PCSK9 inhibitors or PD-1/PD-L1 inhibitors.
- Receiving immunosuppressant or systemic glucocorticoid therapy (except for local low-dose glucocorticoid use).
Other illness
- Active autoimmune diseases or a history of autoimmune diseases.
- 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).
- Other conditions that the investigator deems unfit for participation in the study (e.g., poor compliance, severe organ dysfunction, etc.).
Lab values
- Fasting LDL-C \<1.0 mmol/L (39 mg/dL), only excluding extremely low levels (suggestive of cachexia/severe hepatic disease)
Other
- Pregnant or lactating women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Daping Hospital, Third Military Medical University Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.