Status:
RECRUITING
Immune Checkpoint Inhibitors + Chemotherapy Versus Chemotherapy in the Neoadjuvant Treatment of Locally Advanced Colorectal Cancer
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Locally Advanced Colorectal Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 c...
Detailed Description
A prospective, randomized, open, multi-center clinical study evaluating the efficacy (pathological response, survival outcomes) and safety of the combination of ICIs and FOLFOX regimen compared to FOL...
Eligibility Criteria
Inclusion
- Age 18 to 75, no gender restrictions;
- Histologically or cytologically confirmed colorectal adenocarcinoma;
- Clinically diagnosed as stage II/III colorectal cancer based on CT and/or MRI (according to the 8th edition of AJCC staging);
- Sufficient tumor tissue specimens for mismatch repair protein expression or microsatellite instability testing;
- No prior systemic drug therapy and/or radiotherapy for colorectal adenocarcinoma;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Normal major organ function, no severe blood, heart, lung, liver, kidney dysfunction, or immune deficiency diseases (see protocol for details);
- Voluntary participation in this study and signed informed consent form;
- Expected good compliance to complete the study treatment, follow-up for efficacy and adverse reactions according to the protocol requirements.
Exclusion
- Pathology is other malignant tumors besides adenocarcinoma, such as squamous cell carcinoma, gastrointestinal stromal tumor, melanoma, etc.;
- Within 5 years prior to the first use of investigational drug, diagnosed with other malignant tumors, excluding effectively treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or in situ cervical cancer and/or breast cancer effectively removed;
- Any distant metastatic colorectal adenocarcinoma (according to AJCC 8th edition staging, determined as M1), including but not limited to distant lymph node metastasis, liver metastasis, lung metastasis, intraperitoneal dissemination, or malignant peritoneal effusion;
- Various severe underlying diseases and autoimmune diseases (see protocol for details);
- Unable to control recurrent bleeding or subjects who received blood transfusion within 2 weeks prior to the first use of investigational drug;
- Any other circumstances where the investigator believes it may increase the risk associated with participating in the study, the administration of the investigational drug, or affect the subject's ability to receive the investigational drug and the reliability of the study results.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06154538
Start Date
November 1 2023
End Date
November 1 2028
Last Update
November 28 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Cancer Hospital/ National Cancer Center, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100038
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
3
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250000