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Trial Title:
Xian-Lian-Jie-Du Optimization Decoction as an Adjuvant Treatment for Prevention of Recurrence of Colon Cancer
NCT ID:
NCT05709249
Condition:
Colon Cancer
Conditions: Official terms:
Colonic Neoplasms
Recurrence
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
XLJDOD compound granule
Description:
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.
Arm group label:
intervention group
Intervention type:
Drug
Intervention name:
placebo (XLJDOD mimetic agent)
Description:
The course of placebo in control group will be in accordance with that of XLJDOD in
intervention group.
Arm group label:
control group
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).
Detailed description:
Subjects in the intervention group will be treated with 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. Subjects in the
control group will be treated with placebo (XLJDOD mimetic agent). The course of placebo
in control group will be in accordance with that of XLJDOD in intervention group.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jiangsu Province Hospital of Traditional Chinese Medicine
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yujia Wang
Phone:
18120192802
Start date:
December 1, 2022
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Jiangsu Famous Medical Technology Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Jiangsu Province Hospital of Traditional Chinese Medicine
Agency class:
Other
Source:
Jiangsu Famous Medical Technology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05709249
