Using a Traditional Chinese medicine to prevent colon cancer recurrence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a multi-center, randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy of Xian-Lian-Jie-Du Optimization Decoction (XLJDOD) as an adjuvant treatment for preventing the recurrence of colon cancer. Participants in the intervention group will receive XLJDOD compound granules twice daily for six treatment courses, starting within three months after completing standard adjuvant chemotherapy. The control group will receive a placebo that mimics the XLJDOD treatment. Compliance will be monitored throughout the study to ensure adherence to the treatment regimen.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Colon carcinoma confirmed by pathology.\*

   \*Preoperative endoscopy showed that the distal end of the tumor was ≥12cm from the anal margin. If the patient did not undergo endoscopic examination before surgery, the distance of the tumor from the anal margin was ≥12cm according to the results of intraoperative examination or preoperative imaging examination.
2. Completion of surgical resection of tumors with negative margins (R0 resection) and at least 3 months of adjuvant chemotherapy based on 5-fluorouracil (5-FU). \*

   \*4 cycles of CAPOX (capecitabine and oxaliplatin), 6 cycles of FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or 4 cycles of single agent-5-FU, etc.
3. Within 3 months after the completion of adjuvant chemotherapy.
4. Patients with Stage IIIB or IIIC disease.\*

   \*IIIB: T3-T4aN1/N1cM0, T2-T3N2aM0 and T1-T2N2bM0, IIIC: T4aN2aM0, T3-T4aN2bM0 and T4bN1-N2M0, as defined by the American Joint Committee on Cancer (AJCC) 8th edition).
5. Aged 20-80 years, men or women.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
7. With no radiographic evidence of tumor recurrence.
8. Sign the informed consent form.

Exclusion Criteria:

1. Presence of other malignancies in the past 5 years except curatively treated basal cell carcinoma or cervical carcinoma in situ.
2. Besides adjuvant chemotherapy, other adjuvant therapy such as radiotherapy, targeted therapy and immunotherapy has been used to treat colon cancer.
3. Antitumor Chinese patent medicine and decoction have been used for more than 3 months after surgery or within 1 month before enrollment.
4. Patients with severe comorbidities such as cardiovascular, cerebrovascular, renal, hepatic, hematopoietic system and other severe primary diseases.
5. Allergic to the ingredients of XLJDOD.
6. Any condition that is unstable or can jeopardize the safety of the patients and their compliance to the study, including pregnancy, plan to be pregnant, lactation and psychiatric disorders (schizophrenia, depression, and obsessive-compulsive disorder, etc.).
7. Suspected or confirmed history of alcohol and drug abuse.
8. Patients with other conditions considered by the investigator should not participate in the study.
9. Patients who have recently participated in or are currently participating in other clinical trials of drugs.

Where it's running

• Jiangsu Province Hospital of Traditional Chinese Medicine
  Nanjing, China Recruiting

Study contacts

• Study coordinator: Yujia Wang
• Email: 1217909635@qq.com
• Phone: 18120192802

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.