- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06154538
Cadonilimab + FOLFOX Versus FOLFOX in the Neoadjuvant Treatment of pMMR/MSS Locally Advanced Colorectal Cancer
Comparison of Cetuximab Combined With Chemotherapy Versus Chemotherapy Alone in the Neoadjuvant Treatment of Locally Advanced pMMR/MSS Colorectal Cancer: a Randomized, Open-label, Single-center Phase II Clinical Study
The goal of this clinical trial is to compare the efficacy and safety of the combination of Cadonilimab and FOLFOX regimen compared to FOLFOX regimen alone in the neoadjuvant chemotherapy of pMMR/MSS locally advanced colorectal cancer. The main question aims to answer are:
Question 1: Compare the pathological complete response rate between the combination of Cadonilimab and FOLFOX regimen and the FOLFOX alone.
Question 2: Compare the survival outcomes and safety between the combination of Cadonilimab and FOLFOX regimen and the FOLFOX alone.
Two groups of participants will receive different new adjuvant chemotherapy regimens, and their efficacy will be compared.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Qian Liu
- Phone Number: +8618610506948
- Email: fcwpumch@163.com
Study Contact Backup
- Name: Xiyue Hu
- Phone Number: +8618610506948
- Email: hxy1101bjmu@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100038
- Recruiting
- Cancer Hospital/ National Cancer Center, Chinese Academy of Medical Sciences
-
Contact:
- Xiyue Hu
- Phone Number: +8618610506948
- Email: hxy1101bjmu@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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, with mismatch repair protein expression result of pMMR, or microsatellite instability testing result of MSS;
- 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 Criteria:
- Pathology is adenocarcinoma but mismatch repair protein expression result is dMMR, or microsatellite instability testing result is MSI-H; or 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cadonilimab+FOLFOX group
Patients in this group will receive cetuximab combined with FOLFOX regimen, specifically: Cetuximab 6 mg/kg, intravenous infusion, D1; Oxaliplatin (85mg/m2), intravenous infusion, D1; Calcium folinate (400mg/m2), intravenous infusion, D1; 5-FU (400mg/m2), intravenous infusion, D1, then continuous intravenous infusion of 1200mg/(m2·d)×2d (total amount of 2400mg/m2, infusion for 46-48h) every two weeks; in the control group, qualified subjects will receive Oxaliplatin (85mg/m2), intravenous infusion, D1; Calcium folinate (400mg/m2), intravenous infusion, D1; 5-FU (400mg/m2), intravenous infusion, D1, then continuous intravenous infusion of 1200mg/(m2·d)×2d (total amount of 2400mg/m2, infusion for 46-48h) every two weeks.
Imaging evaluation will be performed after 3 cycles of preoperative treatment.
If the disease is resectable, surgery will be performed.
If R0 resection is achieved, the preoperative regimen will continue for up to 9 cycles.
|
PD-1/CTLA-4 bi-specific antibody
Other Names:
FOLFOX chemotherapy
|
Active Comparator: FOLFOX group
Patients in this group will undergo FOLFOX chemotherapy regimen, specifically: Oxaliplatin 85 mg/m2 dissolved in 500 ml of 5% glucose solution, intravenous drip, on Day 1, in combination with calcium folinate (400mg/m2), intravenous infusion, on Day 1, and 5-FU (400mg/m2), intravenous infusion, on Day 1, followed by continuous intravenous infusion of 1200mg/(m2·d) for 2 days (total dose of 2400mg/m2, infusion for 46-48 hours), once every 2 weeks.
After 3 cycles of preoperative treatment, imaging evaluation will be performed.
If the disease is resectable, surgery will be performed.
If R0 resection is achieved, the preoperative treatment regimen will be continued after surgery, for a maximum of 9 cycles.
|
FOLFOX chemotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pCR rate
Time Frame: at time of surgery
|
pathological complete response rate
|
at time of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
R0 resection rate
Time Frame: at time of surgical assessment (after 3 cycles), up to 12 months
|
R0 resection rate
|
at time of surgical assessment (after 3 cycles), up to 12 months
|
DFS
Time Frame: up to 3 years after intervention
|
disease-free survival
|
up to 3 years after intervention
|
3 years DFS rate
Time Frame: 3 years
|
3 years DFS rate
|
3 years
|
OS
Time Frame: at 1,2,3 years at follow-up time
|
overall survival
|
at 1,2,3 years at follow-up time
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adverse event adverse event rate
Time Frame: 90 days
|
adverse event
|
90 days
|
treatment-related adverse event
Time Frame: 90 days
|
treatment-related adverse event
|
90 days
|
serious adverse event
Time Frame: 90 days
|
serious adverse event
|
90 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Qian Liu, vice director of colorectal surgery dept.
- Study Director: Jing Huang, vice director of medical oncology dept.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CancerIHCAMS-NCTplusAK104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Locally Advanced Colorectal Carcinoma
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingMetastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Metastatic Urothelial Carcinoma | Locally Advanced Bladder Urothelial Carcinoma | Locally Advanced Renal Pelvis Urothelial... and other conditionsUnited States
-
Mayo ClinicRecruitingMetastatic Lung Non-Small Cell Carcinoma | Metastatic Clear Cell Renal Cell Carcinoma | Resectable Lung Non-Small Cell Carcinoma | Metastatic Malignant Solid Neoplasm | Metastatic Bladder Urothelial Carcinoma | Metastatic Colorectal Carcinoma | Metastatic Triple-Negative Breast Carcinoma | Locally... and other conditionsUnited States
-
Emory UniversityAstex Pharmaceuticals, Inc.RecruitingHead and Neck Carcinoma of Unknown Primary | Locally Advanced Head and Neck Squamous Cell Carcinoma | Locally Advanced Hypopharyngeal Squamous Cell Carcinoma | Locally Advanced Laryngeal Squamous Cell Carcinoma | Locally Advanced Nasopharyngeal Squamous Cell Carcinoma | Locally Advanced Oropharyngeal...United States
-
Memorial Sloan Kettering Cancer CenterRecruitingSkin Cancer | Squamous Cell Carcinoma | Cutaneous Squamous Cell Carcinoma | Locally Advanced Skin Squamous Cell Carcinoma | Locally Advanced Cutaneous Squamous Cell Carcinoma | Locally Advanced Squamous Cell Carcinoma | Locally Advanced Squamous Cell Carcinoma of the SkinUnited States
-
Assiut UniversityNot yet recruitingLocally Advanced Cervical Carcinoma
-
Shanghai Runshi Pharmaceutical Technology Co., LtdJilin Provincial Tumor HospitalRecruitingLocally Advanced Unresectable CarcinomaChina
-
Roswell Park Cancer InstituteNational Center for Advancing Translational Sciences (NCATS)Not yet recruitingRecurrent Colorectal Carcinoma | Locally Advanced Colorectal Carcinoma | Stage III Colorectal CancerUnited States
-
Emory UniversityNational Cancer Institute (NCI)RecruitingMetastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Metastatic Urothelial Carcinoma | Stage IV Bladder Cancer AJCC v8 | Stage IV Renal Pelvis Cancer AJCC v8 | Stage IV Ureter Cancer... and other conditionsUnited States
-
Mamta ParikhNational Cancer Institute (NCI); Karyopharm Therapeutics IncRecruitingMetastatic Urothelial Carcinoma | Locally Advanced Urothelial Carcinoma | Advanced Urothelial Carcinoma | Refractory Urothelial CarcinomaUnited States
-
Beijing Friendship HospitalChanghai Hospital; The First Affiliated Hospital of Anhui Medical University; Fudan University and other collaboratorsRecruiting
Clinical Trials on Cadonilimab
-
The First Hospital of Jilin UniversityNot yet recruiting
-
Peking University Cancer Hospital & InstituteNot yet recruitingSoft Tissue Sarcoma
-
Shanghai Pharmaceuticals Holding Co., LtdRecruiting
-
Second Affiliated Hospital of Zunyi Medical UniversityGuizhou Provincial People's Hospital; The First People's Hospital of Zunyi; Guizhou... and other collaboratorsRecruitingImmunotherapy | Second-line TreatmentChina
-
Wuhan Union Hospital, ChinaRecruiting
-
Guangzhou Institute of Respiratory DiseaseRecruiting
-
Guangzhou Institute of Respiratory DiseaseRecruiting
-
M.D. Anderson Cancer CenterRecruitingCervical Cancer | Cervix Cancer | CarcinomasUnited States
-
Tianjin Medical University Cancer Institute and...RecruitingAdvanced Biliary Systemic Tumours That Has Failed at Least One Prior Systemic TherapyChina
-
West China Second University HospitalThe Affiliated Hospital Of Southwest Medical University; Affiliated Hospital...Recruiting