NCT05709249

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
730

participants targeted

Target at P75+ for phase_3

Timeline
23mo left

Started Dec 2022

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Dec 2022Apr 2028

Study Start

First participant enrolled

December 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

December 30, 2024

Status Verified

December 1, 2024

Enrollment Period

4.3 years

First QC Date

January 17, 2023

Last Update Submit

December 27, 2024

Conditions

Colon Cancer

Keywords

colon cancerTraditional Chinese medicine

Outcome Measures

Primary Outcomes (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.

    Assess once 24 months after randomization

Secondary Outcomes (6)

  • Three-year disease-free survival (DFS)

    Assess once 36 months after randomization

  • One, two, three-year relapse rate (RR)

    Assess at month 12, 24, 36 after randomization

  • Three-year survival rate

    Assess once 36 months after randomization

  • Overall survival (OS)

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

  • Changes in total score on the EORTCQLQ-C30 Scale

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

  • +1 more secondary outcomes

Study Arms (2)

intervention group

ACTIVE COMPARATOR

Subjects in the intervention group will be treated with XLJDOD compound granule.

Drug: XLJDOD compound granule

control group

PLACEBO COMPARATOR

Subjects in the control group will be treated with placebo (XLJDOD mimetic agent).

Drug: placebo (XLJDOD mimetic agent)

Interventions

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.

intervention group
placebo (XLJDOD mimetic agent)DRUG

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

control group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.\*
  • \*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.

You may not qualify if:

  • 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.).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Province Hospital of Traditional Chinese Medicine

Nanjing, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37461034DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Central Study Contacts

Yujia Wang

CONTACT

181201928021217909635@qq.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2023

First Posted

February 2, 2023

Study Start

December 1, 2022

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

December 30, 2024

Record last verified: 2024-12

Locations

CN(1)