Envafolimab Monotherapy or Envafolimab + CAPEOX as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer
NCT ID: NCT06014372
Last Updated: 2024-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
55 participants
INTERVENTIONAL
2023-07-01
2026-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Envafolimab Group
Patients diagnosed with colon cancer, with T stage determined as 3-4 based on enhanced MR imaging, or with any T stage accompanied by imaging findings suggestive of lymph node metastasis, and excluding patients with distant metastasis, who are confirmed to have microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) colon cancer, will be enrolled in Group A
Envafolimab
Upon confirming eligibility based on inclusion criteria and obtaining signed informed consent, the patient will be administered Envafolimab at a dose of 300mg every 3 weeks (Q3W) for a total of 4 cycles, starting on Day 1.
Envafolimab+CAPEOX Group
Patients diagnosed with colon adenocarcinoma, with T stage determined as 3-4 based on enhanced MR imaging, or with any T stage accompanied by imaging findings suggestive of lymph node metastasis, and excluding patients with distant metastasis, who are confirmed to have microsatellite stable (MSS)/proficient mismatch repair (pMMR) colon cancer, will be enrolled in Group B.
Envafolimab
Upon confirming eligibility based on inclusion criteria and obtaining signed informed consent, the patient will be administered Envafolimab at a dose of 300mg every 3 weeks (Q3W) for a total of 4 cycles, starting on Day 1.
CAPEOX
The neoadjuvant treatment regimen will consist of Oxaliplatin at a dose of 130mg/m2, administered intravenously over a period of more than 2 hours on Day 1, every 3 weeks; and Capecitabine at a dose of 1000mg/m2, orally, twice daily from Day 1 to Day 14, every 3 weeks, for a total of 4 cycles.
Interventions
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Envafolimab
Upon confirming eligibility based on inclusion criteria and obtaining signed informed consent, the patient will be administered Envafolimab at a dose of 300mg every 3 weeks (Q3W) for a total of 4 cycles, starting on Day 1.
CAPEOX
The neoadjuvant treatment regimen will consist of Oxaliplatin at a dose of 130mg/m2, administered intravenously over a period of more than 2 hours on Day 1, every 3 weeks; and Capecitabine at a dose of 1000mg/m2, orally, twice daily from Day 1 to Day 14, every 3 weeks, for a total of 4 cycles.
Eligibility Criteria
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Inclusion Criteria
* Clinical stage T3-4 or T any N1
* With or without MRF positivity, with or without EMVI positivity
* R0 resection is estimated
* Age ranged from 18 to 70
Exclusion Criteria
* Distance metastasis
* Multiple primary tumor
* Cachexy
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Zhen-Hai Lu
Prof.
Locations
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Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-FXY-256-Department of CRC
Identifier Type: -
Identifier Source: org_study_id
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