Clinical trial NCT02975661: Registry of Huaier Granule for Prevention of Recurrence and Metastasis of Gastrointestinal Cancer After Radical Surgery
Official title: Registry of Huaier Granule for Prevention of Recurrence and Metastasis of Gastrointestinal Cancer After Radical Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gastrointestinal Cancer
Lead sponsor: Qidong Gaitianli Medicines Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Second Hospital of Jilin University
name: Huazhong University of Science and Technology
First posted: 2016-11-29
Enrollment: 740
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after gastrointestinal cancer radical surgery.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease free survival (DFS)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Disease situation
timeFrame: Baseline period
measure: Quality of Life Score
timeFrame: Up to 2 years
measure: Postoperative treatment methods
timeFrame: Up to 2 years
measure: Concomitant medication
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Qiqihar
country: China
facility: The First Affiliated Hospital of Qiqihar Medical College
state: Heilongjiang
city: Hailar
country: China
facility: Hulunbuir People's Hospital
state: Inner Mongolia
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: Affiliated Zhongshan Hospital of Dalian University
state: Liaoning
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Jinzhou
country: China
facility: The First Affiliated Hospital of Jinzhou Medical University
state: Liaoning
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
Study officials:
affiliation: Second Hospital of Jilin University
name: Tongjun Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: