Actively Recruiting
The Efficacy of JS001 Combined With Chemotherapy in Patients With Locally Advanced Colon Cancer
Led by Xiangya Hospital of Central South University · Updated on 2020-12-17
40
Participants Needed
1
Research Sites
284 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Colon cancer is one of the most lethal malignancies, and colorectal cancer ranks the fifth leading cause of tumor-related mortality in China. FOLFOX is the recommended adjuvant/ neoadjuvant treatment for advanced colon cancer. JS001, as the first Chinese produced anti-PD-1 monoclonal antibody, has been approved by CFDA. This study aims to assess the safety and efficacy of JS001 in combination with FOLFOX as adjuvant/neoadjuvant treatment for patients with locally advanced colon cancer.
CONDITIONS
Official Title
The Efficacy of JS001 Combined With Chemotherapy in Patients With Locally Advanced Colon Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with locally advanced colon cancer by biopsy and meeting indications for neoadjuvant chemotherapy
- Patients eligible for surgery
- At least one measurable tumor lesion according to RECIST 1.1
- Male or female patients aged 18 years or older
- ECOG performance status of 0 or 1 with estimated life expectancy of at least 1 year
- Normal major organ and bone marrow function including specified blood counts and liver function within defined limits
- Acceptable lung and cardiac function as defined by specified tests and measurements
- Agreement to use contraception during the study and for 6 months after
- Negative pregnancy test within 7 days before enrollment and not breastfeeding
- Voluntary informed consent and ability to comply with study procedures
You will not qualify if you...
- History of active autoimmune diseases or inflammatory bowel disease
- Use of vaccines against infectious diseases within 4 weeks before starting treatment
- Active systemic infection or positive hepatitis B or C tests
- Positive HIV/AIDS history or test
- Severe or uncontrolled diseases including unstable heart conditions, uncontrolled infections, liver diseases, poorly controlled diabetes, significant urinary protein, or psychiatric disorders
- Previous anti-tumor treatments including chemotherapy, radiotherapy, immunotherapy, or ongoing anticancer drugs
- Major surgery within 3 weeks before enrollment
- History of previous cancers unless in complete remission for at least 2 years
- Previous or active interstitial lung disease or pneumonia within 4 weeks before treatment
- Use of immunosuppressive drugs within 2 weeks before treatment except low-dose glucocorticoids
- Pregnant or breastfeeding women
- Prisoners or those legally detained
- Bleeding disorders or treatment with anticoagulants
- Allergic reactions to study treatments
- Serious concurrent illnesses that may affect safety or study completion
- Vaccination within 30 days before study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shan Zeng
Changsha, Hunan, China, 410008
Actively Recruiting
Research Team
S
Shan Zeng, Ph.D, MD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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