Exploratory Study of ART-123 for the Prevention of Cancer Treatment Related Symptoms in Patients With Postoperative Stage II / III Colon Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of ART-123 for the prevention of cancer treatment related symptoms in patients with postoperative stage II / III colon cancer.

Official Title
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Phase 2 Clinical Study of ART-123 for the Prevention of Cancer Treatment Related Symptoms in Patients With Postoperative Stage II / III Colon Cancer: a Multicenter Randomized Placebo-controlled Double-blind Study to Investigate the Efficacy and Safety of ART-123

Conditions
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Postoperative Stage II/III Colon Cancer

Intervention / Treatment
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* Drug: ART-123 (3-day ART)
* Drug: ART-123 (1-day ART)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Diagnosed with stage II / III colon cancer Deemed to have undergone curative A (Cur A) surgery Planning to undergo postoperative adjuvant chemotherapy Main Exclusion Criteria: Have a history of hypersensitivity to any of the ingredients in thrombomodulin alfa (recombinant) Have any treatment history of systemic chemotherapy (including any drug in the clinical trial stage) or radiotherapy With active double cancer

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ART-123 (3-day ART)<br> | Drug: ART-123 (3-day ART)<br>* ART-123 380 U/kg infusion once daily on days 1-3 in each cycle<br>|
| Experimental: ART-123 (1-day ART)<br> | Drug: ART-123 (1-day ART)<br>* ART-123 380 U/kg infusion once on day 1 and placebo infusion once daily on days 2-3 in each cycle<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo infusion once daily on days 1-3 in each cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cumulative incidences of NCI-CTCAE grade 2 or higher peripheral sensory neuropathy | NCI-CTCAE was used for investigator-reported outcomes of peripheral sensory neuropathy; it was assessed every day from day 1 to day 3 of each cycle and on days 15 and 43 of cycle 12. Once grade 2 or higher neuropathy was observed in a certain participant, that participant was categorized as grade 2 or higher even if the grade returned to 1 or lower in subsequent cycles. Participants who discontinued the study or whose evaluation data were missing without reaching grade 2 or higher neuropathy were analyzed as no grade 2 or higher neuropathy. No primary endpoint was specified due to the exploratory nature of the study. | Cycle 12（each cycle is 2 weeks） | 
| Least-squares (LS) means of Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 (FACT/GOG-Ntx-12) version 4.0 score at cycle 12 | Participant-reported outcomes were evaluated using the FACT/GOG-Ntx-12 version 4.0, which measured the severity and impact of symptoms of neuropathy over the past 7 days. Scores range from 0 to 48, with lower scores indicating more severe neurotoxicity. Participants completed paper questionnaires on days 1 and 8 of each cycle and on days 15 and 43 of cycle 12, with follow-up assessment on the last day (day 43). LS means were calculated from the mixed effect model for repeated measures (MMRM). No primary endpoint was specified due to the exploratory nature of the study. | Cycle 12（each cycle is 2 weeks） | 
| The discontinuation rate of oxaliplatin due to OIPN | The number of people who discontinued oxaliplatin because of OIPN was counted and the percentage of the total was calculated. No primary endpoint was specified due to the exploratory nature of the study. | Cycle 12（each cycle is 2 weeks） |