Last updated: May 7, 2024
Sponsor: Health Science Center of Xi'an Jiaotong University
Overall Status: Active - Recruiting
Phase
4
Condition
Digestive System Neoplasms
Treatment
chemotherapy drugs
Huaier granule
Clinical Study ID
NCT06368063
HE-202301
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age range from 18 to 80 years old, regardless of gender;
- Pancreatic cancer was diagnosed by histopathology after radical surgery within 12weeks before enrollment;
- Did not receive neoadjuvant therapy before surgery and did not receive any adjuvanttherapy after surgery;
- ECOG score 0-3 points;
- Those who choose to use standard chemotherapy independently based on their ownsituation, or choose Huaier granules for subsequent treatment, voluntarily participatein and cooperate with various research work, including but not limited to cooperatingwith treatment and follow-up, cooperating with researchers for data collection, andnot actively taking other treatments.
- The subjects voluntarily signed a written informed consent form before participatingin this study.
Exclusion
Exclusion Criteria:
- Known to be allergic to the components of Huaier granules or to avoid or use Huai ergranules with caution (Huaier group);
- Difficulties in taking oral medication due to active gastrointestinal bleeding,perforation, gastric paralysis, etc;
- Suffering from serious mental illness or other reasons that the researcher deemsunsuitable to participate in this study.
- History of merging with other malignant tumors;
- Patients with concomitant myocardial infarction, cerebral infarction, and otherthromboembolic diseases requiring surgical treatment;
- Concomitant severe infection;
- Child Pugh C-grade liver function, renal function 2-5 grades (glomerular filtrationrate<90ml/min);
- Pregnant or lactating women or those planning to conceive;
- The patient has received other traditional Chinese patent medicines and simplepreparations with anti-tumor effect, chemotherapy or physical therapy in the past 4weeks(including but not limited to compound cantharidin capsules, cinobufotalincapsules, Kangai injection, please refer to the drug instructions for details).
Study Design
Total Participants: 642
Treatment Group(s): 2
Primary Treatment: chemotherapy drugs
Phase: 4
Study Start date:
May 06, 2024
Estimated Completion Date:
March 31, 2028
Study Description
Connect with a study center
Zheng Wang
Xi'an, Shannxi 710065
ChinaActive - Recruiting
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