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NCT Number: NCT07840677

Tafolecimab Combined With Chemoimmunotherapy as Neoadjuvant Treatment for pMMR/MSS Locally Advanced Colon Cancer

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 .

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Daping Hospital Third Military Medical University

Chongqing, Chongqing Municipality, 400000, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Tafolecimab

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

Sintilimab

Drug
  • 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.

Primary outcomes

  1. 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

Secondary outcomes

  1. MPR (Major Pathological Response)

    Time frame: MPR rate assessed postoperatively, at an average of 12 weeks

    MPR is defined as ≤10% residual viable tumor cells in the primary tumor bed of the surgical specimen following neoadjuvant therapy

  2. Disease-free survival

    Time frame: 3 years

    Defined as the time from randomization to relapse or death, whichever occurred first.

  3. Overall survival (OS)

    Time frame: 3 years

    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

  4. Primary tumor downstaging rate

    Time frame: From enrollment to 12 Weeks of treatment end

    Down-staging of the resected tumour as measured by histopathological tumour diameter and stage according to the TNM staging system of AJCC (9th version).

  5. R₀ (Curative) resection

    Time frame: Surgical operation assessment

    Curative resection defined as complete tumor resection with all margins being negative.

  6. Objective Response Rate (ORR)

    Time frame: After 4 cycles of neoadjuvant therapy (10 weeks)

    Objective response is defined as a complete response (CR) or response (PR) according to RECIST v1.1

  7. Radiological response based on RECIST 1.1 criteria: CR, PR, SD, PD

    Time frame: From enrollment to 12 Weeks of treatment end

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Sponsors and collaborators

Lead sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Other

Collaborators

  • 940 Hospital of the People's Liberation Army Joint Logistic Support Force
  • Chongqing Yongchuan District People's Hospital, Deyang People's Hospital
  • Guang'an People's Hospital, Kaizhou District People's Hospital
  • Jiangbei Campus of The First Affiliated Hospital of Army Medical University (Army 958 Hospital)
  • Shapingba District People's Hospital
  • The Second Affiliated Hospital of Chongqing Medical University
  • Third Affiliated Hospital of Chongqing Medical University

Registry information

Official study 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)

Acronym: TRIUNITE-08

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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