NCT07468630 Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma
| NCT ID | NCT07468630 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University |
| Condition | Colon Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 106 participants |
| Start Date | 2026-04-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 106 participants in total. It began in 2026-04-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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+). 106 patients are 1:1 randomized to the combination or chemoimmunotherapy alone, with pCR as the primary endpoint.
Eligibility 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.).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07468630 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Colon Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07468630 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07468630 currently recruiting?
Yes, NCT07468630 is actively recruiting participants. Contact the research team at levinecq@163.com for enrollment information.
Where is the NCT07468630 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT07468630 clinical trial?
NCT07468630 is sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. The trial plans to enroll 106 participants.