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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Gastrointestinal Cancer

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.

• Study Type: Observational
• Enrollment (Actual): 740

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients after gastrointestinal cancer radical surgery.

Description

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:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Observational 1; Huaier Granule
Observational 2; Radiotherapy or chemotherapy
Observational 3; treatment abandoned
Observational 4; Huaier Granule & Radiotherapy or chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival (DFS)	Time from enrollment to tumor recurrence or death with any cause	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease situation	Generally refers to tumor staging, classification, surgical methods, etc	Baseline period
Postoperative treatment methods	Generally including treatment plan, compliance, etc	Up to 2 years
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.	Up to 2 years
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.	Up to 2 years

Collaborators and Investigators

• Sponsor: Qidong Gaitianli Medicines Co., Ltd
• Collaborators: Huazhong University of Science and Technology; Second Hospital of Jilin University
• Investigators: Principal Investigator: Tongjun Liu, PhD, Second Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2017
• Primary Completion (Actual): October 20, 2023
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: November 24, 2016
• First Submitted That Met QC Criteria: November 24, 2016
• First Posted (Estimated): November 29, 2016

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Digestive System Neoplasms; Gastrointestinal Diseases; Recurrence; Gastrointestinal Neoplasms
• Other Study ID Numbers: HE-201601

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No