Xian-Lian-Jie-Du Optimization Decoction As an Adjuvant Treatment for Prevention of Recurrence of Colon Cancer
NCT ID: NCT05709249
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
730 participants
INTERVENTIONAL
2022-12-01
2028-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
intervention group
Subjects in the intervention group will be treated with XLJDOD compound granule.
XLJDOD compound granule
Treatment will begin within 3 months after standard adjuvant chemotherapy and compliance will be continuously monitored. XLJDOD will be taken twice a day, infused with warm water, 1 hour after lunch and dinner. One course of treatment will take 28 days in 1 month, and 2- to 3-day rest. Treatment will continue for 6 courses.
control group
Subjects in the control group will be treated with placebo (XLJDOD mimetic agent).
placebo (XLJDOD mimetic agent)
The course of placebo in control group will be in accordance with that of XLJDOD in intervention group.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
XLJDOD compound granule
Treatment will begin within 3 months after standard adjuvant chemotherapy and compliance will be continuously monitored. XLJDOD will be taken twice a day, infused with warm water, 1 hour after lunch and dinner. One course of treatment will take 28 days in 1 month, and 2- to 3-day rest. Treatment will continue for 6 courses.
placebo (XLJDOD mimetic agent)
The course of placebo in control group will be in accordance with that of XLJDOD in intervention group.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
\*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
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.
20 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jiangsu Province Hospital of Traditional Chinese Medicine
OTHER
Ministry of Science and Technology of the People´s Republic of China
OTHER_GOV
Jiangsu Famous Medical Technology Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jiangsu Province Hospital of Traditional Chinese Medicine
Nanjing, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yujia Wang
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Geng X, Wang Z, Feng L, Gu Y, Wang R, Yao Q, Xu Y, Wu J, Jiang Z, Chen K, Hu W, Tang D, Huo J, Li L, Bu Q, Zhao S, Zhang B, Cheng H. Efficacy and safety of Xian-Lian-Jie-Du optimization decoction as an adjuvant treatment for prevention of recurrence in patients with stage IIIB/IIIC colon cancer: study protocol for a multicentre, randomized controlled trial. BMC Complement Med Ther. 2023 Jul 17;23(1):239. doi: 10.1186/s12906-023-04052-2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022NL-203-02
Identifier Type: -
Identifier Source: org_study_id