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Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 Alone in Locally Advanced Colorectal Cancer: a Randomized Control Phase II Study (OPTICAL-2)

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Trial Profile

Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 Alone in Locally Advanced Colorectal Cancer: a Randomized Control Phase II Study (OPTICAL-2)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 06 Aug 2025

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At a glance

  • Drugs Cadonilimab (Primary) ; Fluorouracil (Primary) ; Folinic acid (Primary) ; Irinotecan (Primary) ; Oxaliplatin (Primary)
  • Indications Adenocarcinoma; Colorectal cancer
  • Focus Therapeutic Use
  • Acronyms OPTICAL-2

Most Recent Events

  • 23 Jul 2025 The protocol has been amended to include an addition group - Group D ((exploratory cohort): mFOLFOXIRI combined with Cadonilimab (AK104) and fruquintinib for 3 months before surgery.
  • 23 Jul 2025 Planned End Date changed from 15 Dec 2025 to 15 Aug 2027.
  • 23 Jul 2025 Planned primary completion date changed from 15 Dec 2024 to 31 Dec 2024.

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