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Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer

ConditionsResectable Colon CancerMSI-H/dMMR Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso

About this trial

This is a randomized, open-label, controlled, multicenter phase 3 study. All patients are resectable microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer. The purpose of this study is to evaluate the efficacy and safety of neoadjuvant/adjuvant treatment of AK104 (Cadonilimab) versus adjuvant chemotherapy in patients with resectable MSI-H/dMMR colon cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily sign a written ICF.

≥ 18, ≤ 75 years old at the time of enrollment, regardless of sex.

Eastern Cooperative Oncology Organization (ECOG) performance status score of 0 or 1.

Life expectancy greater than 2 years.

Disqualifiers

Previously received any anti-tumor treatment for the study disease, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.

Previously (within 3 years) or currently suffering from other malignant tumors, except for cured local tumors (such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, etc.).

Participated in treatment with investigation drugs or used investigation devices within 4 weeks prior to randomization.

History of immunodeficiency; tested positive for HIV antibodies; currently on long-term systemic corticosteroids or other immunosuppressive agents.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cadonilimab (AK104)

    Drug

    Anti-PD-1/CTLA-4 tetrameric bispecific antibody

  • Oxaliplatin

    Drug

    Intravenous

  • Capecitabine

    Drug

    Oral

  • 5- Fluorouracil

    Drug

    Intravenous

  • Calcium Folinate

    Drug

    Intravenous

Treatment groups

386 Participants
are divided into 2 treatment groups
Group A: AK104Experimental treatment 1 intervention
Group B: Physician's choice of chemotherapyActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Pathologic Complete Response (pCR) rate as assessed by investigator

Proportion of participants with post-surgery stage of ypT0N0 as assessed by investigator

Time frame
1 month after surgery
2

Event Free Survival (EFS)

Time from randomization to disease progression, local or distant recurrence in post-surgery phase, or death due to any cause

Time frame
Up to approximately 5 years

Secondary outcomes

1

Overall Survival (OS)

Time from randomization to death from any cause

Time frame
Up to approximately 5 years
2

R0 resection rate

Proportion of R0 resection in participant receiving tumor surgery

Time frame
Up to approximately 2 years
3

Adverse event

Incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory findings

Time frame
Up to approximately 5 years
4

Pharmacokinetics (PK)

Serum concentrations of AK104 (Cadonilimab) at different point of time after AK104 administration

Time frame
Up to approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Akeso

Lead sponsor

Source ClinicalTrials.gov
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