Using a Traditional Chinese medicine to prevent colon cancer recurrence

Efficacy of Xian-Lian-Jie-Du Optimization Decoction As an Adjuvant Treatment for Prevention of Recurrence of Stage IIIB/IIIC Colon Cancer：a Study Protocol for a Randomized Controlled Trial

This study is testing if a traditional Chinese medicine can help prevent colon cancer from coming back in people who have just finished their chemotherapy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 730 (estimated)
• Ages: 20 Years to 80 Years
• Sex: All
• Sponsor: Jiangsu Famous Medical Technology Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Nanjing)
• Trial ID: NCT05709249 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with Stage IIIB or IIIC colon cancer who have completed surgical resection and adjuvant chemotherapy within the last three months.

Not a fit: Patients with earlier-stage colon cancer or those who have not completed standard adjuvant chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of colon cancer recurrence in patients who have undergone surgery and chemotherapy.

How similar studies have performed: While the use of Traditional Chinese medicine in cancer treatment is gaining interest, this specific approach has not been widely tested in similar studies, making it a novel investigation.

Eligibility criteria

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 this trial is running

Nanjing

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

Study contacts

• Study coordinator: Yujia Wang

Conditions Colon Cancer; colon cancer; Traditional Chinese medicine