Adding tolecizumab to chemoimmunotherapy before surgery for locally advanced pMMR/MSS colon cancer
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)
We're testing whether adding tolecizumab (a PCSK9 blocker) to sintilimab plus CapeOX before surgery helps people with pMMR/MSS locally advanced colon cancer (cT3c or higher) achieve a complete tumor response.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Academic / other |
| Drugs / interventions | chemotherapy, tolecizumab, sintilimab |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT07468630 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, randomized, open-label, blinded-endpoint Phase II trial that randomizes 106 patients 1:1 to receive either tolecizumab plus sintilimab with CapeOX or sintilimab with CapeOX alone as four cycles of neoadjuvant therapy. The primary endpoint is the pathological complete response (pCR) rate after neoadjuvant treatment, with secondary endpoints including MPR, ORR, R0 resection rate, PFS, OS, and adverse events by NCI-CTCAE v5.0. Safety follow-up continues for 90 days after last dosing and survival follow-up every 3 months for 3 years, and biological samples will be collected for exploratory biomarker analyses. A DSMB will monitor the study and all study drugs and related exams are provided free to participants.
Who should consider this trial
Good fit: Adults aged 18–80 with pathologically confirmed pMMR/MSS colon adenocarcinoma at cT3c stage or above, ECOG 0–1, tumor located more than 10 cm from the anus, sufficient organ function, and no prior treatment for the current cancer are eligible.
Not a fit: Patients who previously received anti-tumor treatment for this cancer, prior PCSK9 or PD-1/PD-L1 inhibitors, those with active autoimmune disease, or pregnant/lactating individuals are unlikely to qualify or benefit from this regimen.
Why it matters
Potential benefit: If successful, adding tolecizumab could increase the rate of complete tumor eradication before surgery, which may improve long-term outcomes and lower recurrence risk.
How similar studies have performed: Combining PD-1 inhibitors with chemotherapy has produced mixed results in pMMR/MSS colon cancer, and using a PCSK9 inhibitor with chemoimmunotherapy is a novel approach with limited prior clinical data.
Eligibility criteria
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.). 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 this trial is running
Chongqing, Chongqing Municipality
- Daping Hospital Third Military Medical University, chongqing, chongqing 400000 Recruiting — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Study coordinator: fan Li, PhD
- Email: levinecq@163.com
- Phone: 86-18696539200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.