NCT05709249 Xian-Lian-Jie-Du Optimization Decoction As an Adjuvant Treatment for Prevention of Recurrence of Colon Cancer
| NCT ID | NCT05709249 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Jiangsu Famous Medical Technology Co., Ltd. |
| Condition | Colon Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 730 participants |
| Start Date | 2022-12-01 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 730 participants in total. It began in 2022-12-01 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05709249 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Colon Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05709249 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 730 participants.
Is NCT05709249 currently recruiting?
Yes, NCT05709249 is actively recruiting participants. Contact the research team at 1217909635@qq.com for enrollment information.
Where is the NCT05709249 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT05709249 clinical trial?
NCT05709249 is sponsored by Jiangsu Famous Medical Technology Co., Ltd.. The trial plans to enroll 730 participants.
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