ClinicalTrials.gg
Status unknownNCT02975661Updated Oct 25, 2023

Registry of Huaier Granule for Prevention of Recurrence and Metastasis of Gastrointestinal Cancer After Radical Surgery

An observational study in Gastrointestinal Cancer, sponsored by Qidong Gaitianli Medicines Co., Ltd. Status unknown at 12 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-10-25.

Sponsored by Qidong Gaitianli Medicines Co., Ltd · Observational

The sponsor has not verified this record recently (last verified Oct 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
740
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Registration of patients after gastrointestinal cancer radical surgery, including the information of treatments, recurrence \& metastasis, adverse events,etc.

Read the detailed description

This study adopts a multicenter, open, and registered research method, and plans to include 840 cases, including 360 cases in the Huaier Granule test group, 360 cases in the radiotherapy and chemotherapy control group, and 120 cases in the blank group. Using natural grouping, the registered objects are not pre grouped or queue divided, and the diagnosis, treatment, efficacy, and safety of gastrointestinal malignant tumor patients are accurately recorded under real conditions.

02

Conditions studied

  • Gastrointestinal Cancer
03

In context

Gastrointestinal Neoplasms

795 studies on the registry are indexed under Gastrointestinal Neoplasms; 235 are open to participants now.

This study's enrollment of 740 is above the median of 198 across 181 observational studies indexed under Gastrointestinal Neoplasms.

Browse Gastrointestinal Neoplasms studies →

Lead sponsor

Qidong Gaitianli Medicines Co., Ltd is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients after gastrointestinal cancer radical surgery.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with gastrointestinal cancer (stomach, colon or rectum);
  2. Patients who have received gastrointestinal cancer radical surgery within a month;
  3. Patients between 18 and 70 years old,no gender restriction;
  4. Patients volunteer to participate this study and have signed the informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. No chemotherapy or combined radiation and chemotherapy indications;
  2. Unable to cooperate to complete related information collection;
  3. Participation in any other clinical trial within three months;
  4. Conditions that are considered not suitable for this study investigators.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
740 participants (actual)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • Observational 1

    Huaier Granule

  • Observational 2

    Radiotherapy or chemotherapy

  • Observational 3

    treatment abandoned

  • Observational 4

    Huaier Granule \& Radiotherapy or chemotherapy

06

What researchers measure

Primary outcomes

  1. Disease free survival (DFS)

    Time from enrollment to tumor recurrence or death with any cause

    Time frame: Up to 2 years

Secondary outcomes

  1. Disease situation

    Generally refers to tumor staging, classification, surgical methods, etc

    Time frame: Baseline period

  2. Quality of Life Score

    Evaluate the quality of life of subjects during the trial by using the SF-36 scale.Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.

    Time frame: Up to 2 years

  3. Postoperative treatment methods

    Generally including treatment plan, compliance, etc

    Time frame: Up to 2 years

  4. Concomitant medication

    Other drugs (including chemical drugs, biological products, traditional Chinese patent medicines and simple preparations) taken by the subject in addition to the conventional research drugs during the clinical trial.

    Time frame: Up to 2 years

07

Study locations

12 sites
  • The Second Affiliated Hospital of Harbin Medical University
    Harbin, Heilongjiang 150086, China
  • The First Affiliated Hospital of Qiqihar Medical College
    Qiqihar, Heilongjiang 161005, China
  • Hulunbuir People's Hospital
    Hailar, Inner Mongolia 021008, China
  • Nanjing First Hospital
    Nanjing, Jiangsu 210012, China
  • Northern Jiangsu People's Hospital
    Yangzhou, Jiangsu 225001, China
  • The Second Hospital of Jilin University
    Changchun, Jilin 130041, China
  • Affiliated Zhongshan Hospital of Dalian University
    Dalian, Liaoning 116001, China
  • The First Affiliated Hospital of Dalian Medical University
    Dalian, Liaoning 116011, China
  • The First Affiliated Hospital of Jinzhou Medical University
    Jinzhou, Liaoning 121012, China
  • The First Affiliated Hospital of China Medical University
    Shenyang, Liaoning 110002, China
  • Shanxi Provincial People's Hospital
    Taiyuan, Shanxi 030012, China
  • Shanxi Bethune Hospital
    Taiyuan, Shanxi 030032, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2017 to primary completion in Oct 2023, 80 months.

Of 98 observational studies under Gastrointestinal Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 16. This study's 80 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 24, 2016
First posted
Nov 29, 2016
StartActual
Feb 4, 2017
Primary completionActual
Oct 20, 2023
CompletionEst.
Feb 2024
Last update
Oct 25, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02975661
Lead sponsor
Qidong Gaitianli Medicines Co., Ltd
Collaborators
Second Hospital of Jilin University, Huazhong University of Science and Technology
Responsible party
Sponsor
First posted
Nov 29, 2016
Start date
Feb 4, 2017
Primary completion
Oct 20, 2023
Completion
Feb 2024 (estimated)
Last update
Oct 25, 2023

Study contacts

Tongjun Liu, PhD
principal investigator · Second Hospital of Jilin University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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