Actively Recruiting
Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 in Locally Advanced Colorectal Cancer
Led by Sun Yat-sen University · Updated on 2025-07-23
143
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Neoadjuvant chemoradiotherapy (CRT) followed by total mesenteric excision (TME) and adjuvant chemotherapy was the standard of treatment for locally advanced rectal cancer (LARC) in the past two decades. The main obstacles for improving survival benefit of LARC was distant metastasis. Recently, total neoadjuvant therapy (TNT) had been recommended as new preferred option for LARC. Induction chemotherapy with FOLFOXIRI followed by CRT or short-course radiotherapy followed by FOLFOX chemotherapy had improved survival benefit for LARC. Neoadjuvant immunotherapy had also been explored in pMMR patients with CRC. In the NICHE trial, neoadjuvant therapy with 2 dose of nivolumab and 1 dose of ipilimumab led to 29% of pathological response and 13% of pCR. Cadonilimab (AK104) was a PD-1/CTLA-4 bi-specific antibody. Here, we tried to explore the efficacy of Neoadjuvant Treatment With mFOLFOXIRI with or without Cadonilimab (AK104) Versus mFOLFOX6 in LARC.
CONDITIONS
Official Title
Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 in Locally Advanced Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-70 years
- Histological confirmation of colorectal adenocarcinoma
- ECOG Performance status score of 0 or 1
- For colon cancer: T3 >5mm or T4 stage by contrast-enhanced CT without distant metastasis
- For rectal cancer: T3-4 and/or N+ stage by pelvic MRI, tumor located less than 12 cm from anal margin, no distant metastasis
- Primary rectal tumor assessed as resectable by a multidisciplinary team
- No previous systemic anti-cancer therapy for colorectal cancer
- Adequate organ function as shown by specific laboratory test values within 7 days before treatment
- Willing and able to follow the study protocols and visit schedules
You will not qualify if you...
- Presence of obstruction, active bleeding, or perforation requiring emergency surgery or stent
- Active, known, or suspected autoimmune diseases (with some exceptions)
- HIV infection, AIDS, untreated active hepatitis B or C, or co-infection with hepatitis B and C
- Allergy or intolerance to study drugs or their ingredients
- Major surgery or severe trauma within 4 weeks before enrollment
- Other active malignancies except those disease-free for over 5 years or cured carcinoma in situ
- Prior treatment with PD-1, PD-L1, CTLA-4 antibodies, or similar immune checkpoint drugs
- Recent active coronary artery disease, severe or unstable angina, or myocardial infarction within 6 months
- Recent thrombotic or embolic events within 6 months
- New York Heart Association class II or higher congestive heart failure
- Active inflammatory bowel disease or other colorectal diseases causing chronic diarrhea
- Ongoing treatment-related toxicity grade 1 or higher (except anemia, alopecia, skin pigmentation)
- History of lung diseases such as pulmonary fibrosis or severe pulmonary impairment
- Active tuberculosis or recent anti-TB therapy within 1 year
- Known syphilis infection requiring treatment
- Use of immunosuppressive drugs within 4 weeks before first dose (certain corticosteroids allowed)
- Receipt of live attenuated vaccine within 4 weeks before first dose or during study
- Pregnant or lactating women; women of reproductive age not using effective contraception or men at risk of fathering a child
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Actively Recruiting
Research Team
Y
Yanhong Deng, Ph.D
CONTACT
J
Jianwei Zhang, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here