Actively Recruiting

Phase 3
Age: 20Years - 80Years
All Genders
NCT05709249

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

Age: 20Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Jiangsu Province Hospital of Traditional Chinese Medicine

Nanjing, China

Actively Recruiting

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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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Xian-Lian-Jie-Du Optimization Decoction As an Adjuvant Treatment for Prevention of Recurrence of Colon Cancer | DecenTrialz