Actively Recruiting
Immune Checkpoint Inhibitors + Chemotherapy Versus Chemotherapy in the Neoadjuvant Treatment of Locally Advanced Colorectal Cancer
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-11-28
170
Participants Needed
3
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to compare the efficacy and safety of the combination of immune checkpoint inhibitors (ICIs) and FOLFOX regimen compared to FOLFOX regimen alone in the neoadjuvant chemotherapy of locally advanced colorectal cancer. The main question aims to answer are: Question 1: Compare the pathological complete response rate between the combination of ICIs and FOLFOX regimen and the FOLFOX alone. Question 2: Compare the survival outcomes and safety between the combination of ICIs and FOLFOX regimen and the FOLFOX alone. Two groups of participants will receive different new adjuvant chemotherapy regimens, and their efficacy will be compared.
CONDITIONS
Official Title
Immune Checkpoint Inhibitors + Chemotherapy Versus Chemotherapy in the Neoadjuvant Treatment of Locally Advanced Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75, no gender restrictions
- Histologically or cytologically confirmed colorectal adenocarcinoma
- Clinically diagnosed stage II or III colorectal cancer based on CT and/or MRI
- Sufficient tumor tissue for mismatch repair protein expression or microsatellite instability testing
- No prior systemic drug therapy or radiotherapy for colorectal adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Normal major organ function without severe blood, heart, lung, liver, kidney dysfunction, or immune deficiency
- Voluntary participation with signed informed consent
- Expected good compliance to complete treatment and follow-up according to protocol
You will not qualify if you...
- Pathology showing malignant tumors other than adenocarcinoma (e.g., squamous cell carcinoma, gastrointestinal stromal tumor, melanoma)
- Diagnosis of other malignant tumors within 5 years before first investigational drug use, excluding effectively treated basal cell carcinoma, squamous cell carcinoma of the skin, in situ cervical cancer, or breast cancer effectively removed
- Presence of distant metastatic colorectal adenocarcinoma (AJCC M1), including distant lymph node, liver, lung metastasis, intraperitoneal dissemination, or malignant peritoneal effusion
- Severe underlying diseases or autoimmune diseases
- Uncontrolled recurrent bleeding or blood transfusion within 2 weeks before first investigational drug use
- Any condition that the investigator believes increases risk or affects ability to participate or reliability of study results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Cancer Hospital/ National Cancer Center, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100038
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
3
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250000
Actively Recruiting
Research Team
Q
Qian Liu
CONTACT
X
Xiyue Hu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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