Colon AdenocarcinomaPhase 2TRIUNITE-08NCT07468630
Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma
A Phase 2 study testing Tolecizumab (PCSK9 Inhibitor) and Sintilimab in people with Colon Adenocarcinoma, 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 (cT3c+). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Adenocarcinoma
- What is being tested?
- Tolecizumab (PCSK9 Inhibitor) 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
- 106 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2026to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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.).
- 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 400000 Recruiting
Chongqing, Chongqing Municipality
fan Li, PhD, 86-18696539200, levinecq@163.com
About this study
Official title: 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)
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 (cT3c+). 106 patients are 1:1 randomized to the combination or chemoimmunotherapy alone, with pCR as the primary endpoint.
Read the detailed description
This is a multicenter, randomized, open-label, blinded-endpoint Phase II clinical trial designed to evaluate the efficacy and safety of tolecizumab (a PCSK9 inhibitor) combined with chemoimmunotherapy (sintilimab plus CapeOX regimen) as neoadjuvant treatment for patients with pMMR/MSS locally advanced colon adenocarcinoma (cT3c stage or above). A total of 106 eligible patients will be randomized 1:1 into two arms: Arm A (tolecizumab + sintilimab + CapeOX) and Arm B (sintilimab + CapeOX), both receiving 4 cycles of neoadjuvant therapy. The primary endpoint is the pathological complete response rate (pCR) after treatment; secondary endpoints include major pathological response rate (MPR), objective response rate (ORR), R0 resection rate, progression-free survival (PFS), overall survival (OS), and the incidence of adverse events (AEs) graded by NCI-CTCAE V5.0. A virtual historical control (single-agent CapeOX neoadjuvant chemotherapy) is set only for sample size calculation. The study will conduct safety follow-up for up to 90 days after the last administration and survival follow-up every 3 months for a total of 3 years, and also collect biological samples for exploratory biomarker analysis to explore the predictive factors of treatment efficacy. All study drugs and related examinations are provided free of charge for participants, and a Data and Safety Monitoring Board (DSMB) is established to monitor the study process and ensure participant safety.
- Conditions
- Colon Adenocarcinoma
- Being tested
- Tolecizumab (PCSK9 Inhibitor), Sintilimab
- Keywords
- pMMR/MSS, neoadjuvant immunochemotherapy, PCSK9 inhibitor, Tolecizumab
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tolecizumab (PCSK9 Inhibitor)Drug
Also called Sintilimab (PD-1 Inhibitor), CapeOX Regimen (Oxaliplatin + Capecitabine)
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
Also called CapeOX
- 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.
- 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.Monoclonal Antibody 2. Immunotherapy 3. Chemotherapy | Experimental | 1. Tolecizumab (PCSK9 inhibitor) 600mg, subcutaneous injection, Q6W (Weeks 1,7), total 2 doses
2. Sintilimab (PD-1 inhibitor) 200mg, intravenous infusion, Q3W (Weeks1,4,7,10), total 4 cycles
3. CapeOX regimen (Oxaliplatin + Capecitabine) Oxaliplatin 130mg/m², IV infusion Q3W (4 cycles); Capecitabine 1000mg/m², oral twice daily, Days1-14 per cycle Receives: Drug: Tolecizumab (PCSK9 Inhibitor); 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 (6)
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 progression or death to any cause
Measured: 3 years
MPR
After neoadjuvant therapy, the percentage of residual viable tumor cells in the tumor bed ≤ 10%. Regardless of whether there are viable tumor cells left in the lymph nodes
Measured: From enrollment to 12 Weeks of treatment end
Curative resection
Curative resection defined as complete tumor resection with all margins being negative.
Measured: Surgical operation assessment
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
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start10 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon AdenocarcinomaStudies 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
- 106 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
- Southwest Hospital, China, Chongqing Shapingba District People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468630
- Sponsor's protocol ID
- TRIUNITE-08
- Acronym
- TRIUNITE-08
- Status last verified
- Jan 2026
- First submitted
- 9 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07468630
- Acronym / sponsor ID
- TRIUNITE-08 / TRIUNITE-08
- Conditions
- Colon Adenocarcinoma
- Keywords
- pMMR/MSS, neoadjuvant immunochemotherapy, PCSK9 inhibitor, Tolecizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Collaborators
- Southwest Hospital, China, Chongqing Shapingba District People's Hospital
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (cT3c+). 106 patients are 1:1 randomized to the combination or chemoimmunotherapy alone, with pCR as the primary endpoint.
Detailed description
This is a multicenter, randomized, open-label, blinded-endpoint Phase II clinical trial designed to evaluate the efficacy and safety of tolecizumab (a PCSK9 inhibitor) combined with chemoimmunotherapy (sintilimab plus CapeOX regimen) as neoadjuvant treatment for patients with pMMR/MSS locally advanced colon adenocarcinoma (cT3c stage or above). A total of 106 eligible patients will be randomized 1:1 into two arms: Arm A (tolecizumab + sintilimab + CapeOX) and Arm B (sintilimab + CapeOX), both receiving 4 cycles of neoadjuvant therapy. The primary endpoint is the pathological complete response rate (pCR) after treatment; secondary endpoints include major pathological response rate (MPR), objective response rate (ORR), R0 resection rate, progression-free survival (PFS), overall survival (OS), and the incidence of adverse events (AEs) graded by NCI-CTCAE V5.0. A virtual historical control (single-agent CapeOX neoadjuvant chemotherapy) is set only for sample size calculation. The study will conduct safety follow-up for up to 90 days after the last administration and survival follow-up every 3 months for a total of 3 years, and also collect biological samples for exploratory biomarker analysis to explore the predictive factors of treatment efficacy. All study drugs and related examinations are provided free of charge for participants, and a Data and Safety Monitoring Board (DSMB) is established to monitor the study process and ensure participant safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.Monoclonal Antibody 2. Immunotherapy 3. Chemotherapy | Experimental | Drug: Tolecizumab (PCSK9 Inhibitor), Drug: Sintilimab1. Tolecizumab (PCSK9 inhibitor) 600mg, subcutaneous injection, Q6W (Weeks 1,7), total 2 doses 2. Sintilimab (PD-1 inhibitor) 200mg, intravenous infusion, Q3W (Weeks1,4,7,10), total 4 cycles 3. CapeOX regimen (Oxaliplatin + Capecitabine) Oxaliplatin 130mg/m², IV infusion Q3W (4 cycles); Capecitabine 1000mg/m², oral twice daily, Days1-14 per cycle |
| 1. Immunotherapy 2. Chemotherapy | Experimental | Drug: Sintilimab1. 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tolecizumab (PCSK9 Inhibitor)Also: Sintilimab (PD-1 Inhibitor), CapeOX Regimen (Oxaliplatin + Capecitabine)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 | Drug | 1.Monoclonal Antibody 2. Immunotherapy 3. Chemotherapy |
| SintilimabAlso: CapeOX1. 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. | Drug | 1. Immunotherapy 2. Chemotherapy, 1.Monoclonal Antibody 2. Immunotherapy 3. Chemotherapy |
Primary outcome
pCR
Time frame: The pCR rate will be evaluated after surgery, an average of 12 weeks
pCR was defined as the absence, from surgical samples, of malignant cells in the primary site and regional lymph nodes
6 secondary outcomes
Disease-free survival
Time frame: 3 years
Overall survival (OS)
Time frame: 3 years
MPR
Time frame: From enrollment to 12 Weeks of treatment end
Curative resection
Time frame: Surgical operation assessment
Primary tumor downstaging rate
Time frame: From enrollment to 12 Weeks of treatment end
Objective Response Rate (ORR)
Time frame: After 4 cycles of neoadjuvant therapy (10 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tolecizumab (PCSK9 Inhibitor) and Sintilimab in people with Colon Adenocarcinoma, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact fan Li, PhD (86-18696539200, levinecq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: The pCR rate will be evaluated after surgery, an average of 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.