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

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Famous Medical Technology Co., Ltd.
• Collaborator: Jiangsu Province Hospital of Traditional Chinese Medicine

Criteria

Inclusion Criteria:

1. Colon carcinoma confirmed by pathology.

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.