Actively Recruiting
Xian-Lian-Jie-Du Optimization Decoction As an Adjuvant Treatment for Prevention of Recurrence of Colon Cancer
Led by Jiangsu Famous Medical Technology Co., Ltd. · Updated on 2024-12-30
730
Participants Needed
1
Research Sites
278 weeks
Total Duration
On this page
Sponsors
J
Jiangsu Famous Medical Technology Co., Ltd.
Lead Sponsor
J
Jiangsu Province Hospital of Traditional Chinese Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is designed as a multi-center, randomized, double-blind, placebo-controlled trial. Subjects in the intervention group will be treated with XLJDOD compound granule. Subjects in the control group will be treated with placebo (XLJDOD mimetic agent).
CONDITIONS
Official Title
Xian-Lian-Jie-Du Optimization Decoction As an Adjuvant Treatment for Prevention of Recurrence of Colon Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Colon carcinoma confirmed by pathology with tumor at least 12cm from the anal margin
- Completed surgical tumor removal with negative margins (R0 resection) and at least 3 months of adjuvant chemotherapy based on 5-fluorouracil
- Treatment to begin within 3 months after finishing adjuvant chemotherapy
- Diagnosed with stage IIIB or IIIC colon cancer as defined by AJCC 8th edition
- Age between 20 and 80 years, any gender
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- No radiographic signs of tumor recurrence
- Signed informed consent form
You will not qualify if you...
- Other malignancies within past 5 years except treated basal cell carcinoma or cervical carcinoma in situ
- Received other adjuvant treatments besides chemotherapy such as radiotherapy, targeted therapy, or immunotherapy for colon cancer
- Use of antitumor Chinese patent medicine or decoction for more than 3 months after surgery or within 1 month before enrollment
- Severe comorbidities including cardiovascular, cerebrovascular, renal, hepatic, hematopoietic, or other serious diseases
- Allergy to ingredients of XLJDOD
- Unstable conditions that risk safety or compliance, including pregnancy, lactation, psychiatric disorders
- History or suspicion of alcohol or drug abuse
- Other conditions deemed by investigator to preclude participation
- Current or recent participation in other drug clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jiangsu Province Hospital of Traditional Chinese Medicine
Nanjing, China
Actively Recruiting
Research Team
Y
Yujia Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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