Clinical trial · Interventional
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
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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 .
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Neoadjuvant Immunochemotherapy | — | UNRESOLVED | — |
| PCSK9 Inhibitor | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sintilimab | Drug | Sintilimab | ALIAS |
| Tafolecimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1.Tafolecimab 2. Immunotherapy 3. Chemotherapy
- description
- Tafolecimab 600mg SC Q6W (Weeks 1, 7) + Sintilimab 200mg IV Q3W (Weeks 1, 4, 7, 10) + Oxaliplatin 130mg/m² IV Q3W (Weeks 1, 4, 7, 10) + Capecitabine 1000mg/m² PO BID Days 1-14 of each cycle, 4 cycles total. Arm B (Active Comparator): Sintilimab 200mg IV Q3W (Weeks 1, 4, 7, 10) + Oxaliplatin 130mg/m² IV Q3W (Weeks 1, 4, 7, 10) + Capecitabine 1000mg/m² PO BID Days 1-14 of each cycle, 4 cycles total.
- interventionNames
- Drug: Tafolecimab
- Drug: Sintilimab
- type
- EXPERIMENTAL
- label
- 1. Immunotherapy 2. Chemotherapy
- description
- 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
- interventionNames
- Drug: Sintilimab
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.).
References
Publications (0)
Data not yet available