Actively Recruiting
Comparison of Immune Checkpoint Inhibitors Combined With Chemotherapy Versus Chemotherapy Alone 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
104 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining immune checkpoint inhibitors (ICIs) with the FOLFOX chemotherapy regimen versus using the FOLFOX regimen alone for neoadjuvant treatment in patients with locally advanced colorectal cancer. This phase II, randomized, open-label study aims to compare the pathological complete response rate, survival outcomes, and safety between these two treatment approaches. The study is sponsored by the Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Participants will be assigned to one of two groups. The first group receives ICIs via intravenous infusion on Day 1 combined with the FOLFOX regimen, which includes oxaliplatin, calcium folinate, and 5-FU administered intravenously every two weeks. The second group receives the FOLFOX regimen alone with the same dosing schedule. After three cycles of treatment, imaging will assess if the cancer is resectable, followed by surgery if appropriate. If R0 resection is achieved, preoperative treatment continues for up to nine cycles in both groups. Throughout the trial, participants will undergo assessments including imaging evaluations after three treatment cycles and surgical assessments at the time of surgery. Researchers will monitor pathological complete response rates, R0 resection rates, disease-free survival up to three years, and overall survival at one, two, and three years. Participants will be followed closely for safety and efficacy outcomes, with a maximum follow-up period of three years. The total duration of participation varies according to treatment and follow-up schedules.
CONDITIONS
Brief 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 as stage II or III colorectal cancer based on CT and/or MRI
- Sufficient tumor tissue available for mismatch repair protein or microsatellite instability testing
- No prior systemic drug therapy or radiotherapy for colorectal adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Normal major organ function without severe blood, heart, lung, liver, kidney dysfunction, or immune deficiency
- Voluntary participation with signed informed consent
- Expected to comply with study treatment and follow-up requirements
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 prior, except effectively treated basal cell carcinoma, skin squamous cell carcinoma, in situ cervical cancer, or removed breast cancer
- Presence of distant metastatic colorectal adenocarcinoma (M1 stage), including distant lymph node, liver, lung metastasis, intraperitoneal spread, or malignant peritoneal effusion
- Severe underlying diseases or autoimmune diseases
- Uncontrolled recurrent bleeding or blood transfusion within 2 weeks prior to investigational drug use
- Any condition the investigator believes increases risk or affects ability to participate or reliability of results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 weeks before surgery (up to 9 cycles every 2 weeks)
Participants receive chemotherapy with or without immune checkpoint inhibitors before surgery, with treatment cycles every two weeks. Imaging evaluation occurs after 3 treatment cycles to assess if surgery is possible.
Up to 9 treatment visits every 2 weeks before surgery
Duration - 1 day
Participants undergo surgery if the disease is resectable after preoperative treatment.
1 surgery visit (in-person)
Duration - Up to 18 weeks after surgery (up to 9 cycles every 2 weeks)
Participants continue chemotherapy with or without immune checkpoint inhibitors after surgery for up to 9 cycles every 2 weeks.
Up to 9 treatment visits every 2 weeks after surgery
Duration - Up to 3 years
Participants are monitored for survival and disease-free status for up to 3 years after completing treatment.
Periodic follow-up visits for up to 3 years
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
X
Xiyue Hu
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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