Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma

NCT07468630 | Recruiting Phase 2 DMC

• 1 other identifier: TRIUNITE-08
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Adenocarcinoma

Keywords

pMMR/MSS; neoadjuvant immunochemotherapy; PCSK9 inhibitor; Tolecizumab

Outcome Measures

Primary Outcomes (1)

• pCR

  pCR was defined as the absence, from surgical samples, of malignant cells in the primary site and regional lymph nodes

  The pCR rate will be evaluated after surgery, an average of 12 weeks

Secondary Outcomes (6)

• Disease-free survival

  3 years

• Overall survival (OS)

  3 years

• MPR

  From enrollment to 12 Weeks of treatment end

• Curative resection

  Surgical operation assessment

• Primary tumor downstaging rate

  From enrollment to 12 Weeks of treatment end

Study Arms (2)

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

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

Drug: Sintilimab

Interventions

Tolecizumab (PCSK9 Inhibitor) DRUG

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

Also known as: Sintilimab (PD-1 Inhibitor), CapeOX Regimen (Oxaliplatin + Capecitabine)

1.Monoclonal Antibody 2. Immunotherapy 3. Chemotherapy

Sintilimab DRUG

1. 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.

Also known as: CapeOX

1. Immunotherapy 2. Chemotherapy; 1.Monoclonal Antibody 2. Immunotherapy 3. Chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead
• Southwest Hospital, China: collaborator
• Chongqing Shapingba District People's Hospital: collaborator

Study Sites (1)

Daping Hospital Third Military Medical University, chongqing, chongqing 400000 Recruiting

Chongqing, Chongqing Municipality, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

sintilimab; Immune Checkpoint Inhibitors; XELOX; Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

fan Li, PhD

CONTACT

86-18696539200; levinecq@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)