Colon CancerPhase 2TRIUNITE-08NCT07840677
Tafolecimab Combined With Chemoimmunotherapy as Neoadjuvant Treatment for pMMR/MSS Locally Advanced Colon Cancer
A Phase 2 study testing Tafolecimab and Sintilimab in people with Colon Cancer and PCSK9 Inhibitor, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer, PCSK9 Inhibitor, Neoadjuvant Immunochemotherapy
- What is being tested?
- Tafolecimab and Sintilimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2026to 20 Sep 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.).
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- 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.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Daping Hospital Third Military Medical University
Chongqing, Chongqing Municipality, 400000
fan Li, PhD, 86-18696539200, levinecq@163.com
About this study
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)
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 .
- Being tested
- Tafolecimab, Sintilimab
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TafolecimabDrug
Tolecizumab (PCSK9 Inhibitor) 600mg, subcutaneous injection, Q6W (Weeks 1,7), 2 doses total Sintilimab (PD-1 Inhibitor) 200mg, intravenous infusion, Q3W (Weeks1,4,7,10), 4 cycles total CapeOX Regimen (Oxaliplatin + Capecitabine) Oxaliplatin 130mg/m² IV Q3W (4 cycles); Capecitabine 1000mg/m² oral twice daily, Days1-14 per cycle
SintilimabDrug
- Oxaliplatin: 130mg/m² intravenous infusion, Q3W at Week 1,4,7,10, total 4 cycles; 2. Capecitabine: 1000mg/m² oral administration, twice daily, Days 1-14 of each chemotherapy cycle. All drugs free of charge. 2.Sintilimab 200mg intravenous infusion, administered every 3 weeks (Q3W) at Week 1, 4, 7, 10, total 4 cycles; provided free of charge by the sponsor, used for neoadjuvant immunotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 1.Tafolecimab 2. Immunotherapy 3. Chemotherapy | Experimental | 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. Receives: Drug: Tafolecimab; Drug: Sintilimab |
| 1. Immunotherapy 2. Chemotherapy | Experimental | 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 Receives: Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
pCR was defined as the absence, from surgical samples, of malignant cells in the primary site and regional lymph nodes
Measured: The pCR rate will be evaluated after surgery, an average of 12 weeks
Secondary outcomes (7)
MPR (Major Pathological Response)
MPR is defined as ≤10% residual viable tumor cells in the primary tumor bed of the surgical specimen following neoadjuvant therapy
Measured: MPR rate assessed postoperatively, at an average of 12 weeks
Disease-free survival
Defined as the time from randomization to relapse or death, whichever occurred first.
Measured: 3 years
Overall survival (OS)
Defined as the time from randomization to date of death due to any cause according to RECIST version 1.1 recorded in the time period between randomization and disease
Measured: 3 years
Primary tumor downstaging rate
Down-staging of the resected tumour as measured by histopathological tumour diameter and stage according to the TNM staging system of AJCC (9th version).
Measured: From enrollment to 12 Weeks of treatment end
R₀ （Curative） resection
Curative resection defined as complete tumor resection with all margins being negative.
Measured: Surgical operation assessment
Objective Response Rate (ORR)
Objective response is defined as a complete response (CR) or response (PR) according to RECIST v1.1
Measured: After 4 cycles of neoadjuvant therapy (10 weeks)
Radiological response based on RECIST 1.1 criteria: CR, PR, SD, PD
Measured: From enrollment to 12 Weeks of treatment end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion20 Sep 2029 (estimated)
- Study completion20 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shapingba District People's Hospital, The Second Affiliated Hospital of Chongqing Medical University, Jiangbei Campus of The First Affiliated Hospital of Army Medical University (Army 958 Hospital), Third Affiliated Hospital of Chongqing Medical University, Chongqing Yongchuan District People's Hospital, Deyang People's Hospital, Guang'an People's Hospital, Kaizhou District People's Hospital, 940 Hospital of the People's Liberation Army Joint Logistic Support Force
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840677
- Sponsor's protocol ID
- TRIUNITE--08
- Acronym
- TRIUNITE-08
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No