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Colon CancerPhase 3NCT05709249

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

A Phase 3 study testing XLJDOD compound granule in people with Colon Cancer, run by Jiangsu Famous Medical Technology Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Colon Cancer
What is being tested?
XLJDOD compound granule
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
730 participants
Where
1 siteChina
Study dates
1 Dec 2022to 1 Apr 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
  • Within 3 months after the completion of adjuvant chemotherapy.
  • Patients with Stage IIIB or IIIC disease.*
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  • 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).
  • Aged 20-80 years, men or women.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • With no radiographic evidence of tumor recurrence.
  • Sign the informed consent form.

Who cannot join

  • Presence of other malignancies in the past 5 years except curatively treated basal cell carcinoma or cervical carcinoma in situ.
  • Besides adjuvant chemotherapy, other adjuvant therapy such as radiotherapy, targeted therapy and immunotherapy has been used to treat colon cancer.
  • Antitumor Chinese patent medicine and decoction have been used for more than 3 months after surgery or within 1 month before enrollment.
  • Patients with severe comorbidities such as cardiovascular, cerebrovascular, renal, hepatic, hematopoietic system and other severe primary diseases.
  • Allergic to the ingredients of XLJDOD.
  • 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.).
Show all 9Show fewer
  • Suspected or confirmed history of alcohol and drug abuse.
  • Patients with other conditions considered by the investigator should not participate in the study.
  • Patients who have recently participated in or are currently participating in other clinical trials of drugs.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yujia Wang contact

18120192802

1217909635@qq.com

China1 site, 1 recruiting

  • Jiangsu Province Hospital of Traditional Chinese Medicine

    Nanjing

    Yujia Wang, 18120192802

    Recruiting

Other trials in China

About this study

Official title: 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 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).

Read the 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.

Conditions
Colon Cancer
Being tested
XLJDOD compound granule, placebo (XLJDOD mimetic agent)
Keywords
colon cancer, Traditional Chinese medicine
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XLJDOD compound granuleDrug

    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)Drug

    The course of placebo in control group will be in accordance with that of XLJDOD in intervention group.

Study groups in NCT05709249
Study groupRoleWhat they receive
intervention groupActive comparatorSubjects in the intervention group will be treated with XLJDOD compound granule.
Receives: Drug: XLJDOD compound granule
control groupPlacebo comparatorSubjects in the control group will be treated with placebo (XLJDOD mimetic agent).
Receives: Drug: placebo (XLJDOD mimetic agent)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Two-year disease-free survival (DFS)

    2-year DFS is defined as the percentage of patients alive without disease recurrence at 2 years measured from the randomization date.

    Measured: Assess once 24 months after randomization

Secondary outcomes (6)

  1. Three-year disease-free survival (DFS)

    3-year DFS is defined as the percentage of patients alive without disease recurrence at 3 years measured from the randomization date.

    Measured: Assess once 36 months after randomization

  2. One, two, three-year relapse rate (RR)

    RR is defined as the fraction of followed patients who have disease recurrence. All disease recurrences and deaths from colon cancer are events. Second primary same cancers and other primary cancers will be ignored.

    Measured: Assess at month 12, 24, 36 after randomization

  3. Three-year survival rate

    3-year survival rate is defined as the percentage of patients alive at 3 years measured from the randomization date.

    Measured: Assess once 36 months after randomization

  4. Overall survival (OS)

    OS is measured from the date of enrollment to the date of death, irrespective of cause.

    Measured: Observation to the end of the study，assessed up to 24 months

  5. Changes in total score on the EORTCQLQ-C30 Scale

    The changes of The European O-rganization for Reasearch and Treatment of Cancer score will be compared in the two groups prior to and following XLJDOD compound granule administration. It is a universal scale for all patients with malignant tumors with a total score of 126, ranging from 30 (least severe) to 126 (most severe).

    Measured: Measurement will be performed at baseline and month 6, 12 ,18 ,24, 36.

  6. Changes in total score on the MD Anderson Symptom Inventory for Traditional Chinese Medicine (MDASI-TCM)

    The scale is divided into two parts. The first part mainly assesses the severity of 20 common clinical symptoms and TCM-related symptoms of patients with cancer in the past 24 hours. The second part is the evaluation scale of the interference of the above symptoms with daily functioning. It has a total of 26 items, each with a score of 0-10, leading to a total score of 0-260.

    Measured: Compared with the baseline period, the changes in MDASI-TCM score at month 6, 12 ,18 ,24, 36 will be measured.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2023
  2. Study start1 Dec 2022
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
730 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05709249
Sponsor's protocol ID
2022NL-203-02
Status last verified
Dec 2024
First submitted
17 Jan 2023
Last updated
30 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37461034

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing XLJDOD compound granule in people with Colon Cancer, run by Jiangsu Famous Medical Technology Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yujia Wang (18120192802, 1217909635@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Two-year disease-free survival (DFS) (time frame: Assess once 24 months after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05709249, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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