Trial Title:
The Study of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer
NCT ID:
NCT06368063
Condition:
Pancreatic Cancer Resectable
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Huaier granule
Postoperative adjuvant therapy
Resectable pancreatic cancer
Efficacy and safety
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Huaier granule
Description:
Huaier Granules: Oral administration, 10g once, 3 times a day, starting from 15-30 days
after surgery until the end of the study, intolerable toxicity, withdrawal from the study
for any reason, or death, whichever occurs first; Or the researcher determines that the
subjects no longer benefit.
Arm group label:
Huaier treatment group
Other name:
Z20000109#NMPA Approval Number#
Intervention type:
Drug
Intervention name:
chemotherapy drugs
Description:
Accept treatment with Class 1A chemotherapy drugs recommended by CSCO (choose any one to
receive treatment)
· Gemcitabine combine with capecitabine
Gemcitabine 1000mg/m^2 intravenous infusion for more than 30 minutes, day 1, 8, 15,repeat
every 4 weeks for a total of 6 cycles.
· mFOLFIRINOX solution
Oxaliplatin 85mg/m^2 intravenous infusion for 2 hours, day 1 Ilitacan 150mg/m^2
intravenous infusion for more than 30-90 minutes, day 1 Leucovorin calcium 400mg/m^2
intravenous infusion for 2 hours, day 1 5-FU 2400mg/m^2, continuous intravenous infusion
for 46 hours, repeated every 2 weeks, administered until 24 weeks.
- Gemcitabine monotherapy
1000mg/m^2 intravenous infusion, day 1 qw x 7, rest for 1 week Afterwards, qw × 3,
take a week off, and administer medication for 6 months.
- Tegio capsules monotherapy
Take tegio capsules orally, 80mg/d, day 1-28, repeated every 6 weeks, administered until
6 months.
Arm group label:
Standard chemotherapy group
Other name:
Standard chemotherapy
Summary:
The study is a multicenter, prospective clinical study aimed at evaluating the efficacy
and safety of Huaier Granule in postoperative adjuvant treatment of resectable pancreatic
cancer
Detailed description:
The study is a multicenter, prospective clinical study, expected to include subjects who
visited the selected research center from April 2024 to March 2026, underwent radical
tumor resection surgery, and were pathologically diagnosed with pancreatic
adenocarcinoma. The subjects are divided into two groups. One group is the standard
chemotherapy group, with a planned inclusion of no less than 428 subjects. The
chemotherapy will be treated using the Class 1A chemotherapy regimen recommended by the
2022 version of the CSCO guidelines; One group is the Huaier treatment group, with a
planned inclusion of no less than 214 subjects. All subjects voluntarily give up the
postoperative adjuvant treatment recommended by the guidelines and only choose Huaier
granules for postoperative adjuvant treatment. A total of no less than 642 subjects are
planned to be included.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age range from 18 to 80 years old, regardless of gender;
- Pancreatic cancer was diagnosed by histopathology after radical surgery within 12
weeks before enrollment;
- Did not receive neoadjuvant therapy before surgery and did not receive any adjuvant
therapy after surgery;
- ECOG score 0-3 points;
- Those who choose to use standard chemotherapy independently based on their own
situation, or choose Huaier granules for subsequent treatment, voluntarily
participate in and cooperate with various research work, including but not limited
to cooperating with treatment and follow-up, cooperating with researchers for data
collection, and not actively taking other treatments.
- The subjects voluntarily signed a written informed consent form before participating
in this study.
Exclusion Criteria:
- Known to be allergic to the components of Huaier granules or to avoid or use Huai er
granules 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 deems
unsuitable to participate in this study.
- History of merging with other malignant tumors;
- Patients with concomitant myocardial infarction, cerebral infarction, and other
thromboembolic diseases requiring surgical treatment;
- Concomitant severe infection;
- Child Pugh C-grade liver function, renal function 2-5 grades (glomerular filtration
rate<90ml/min);
- Pregnant or lactating women or those planning to conceive;
- The patient has received other traditional Chinese patent medicines and simple
preparations with anti-tumor effect, chemotherapy or physical therapy in the past 4
weeks(including but not limited to compound cantharidin capsules, cinobufotalin
capsules, Kangai injection, please refer to the drug instructions for details).
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zheng Wang
Address:
City:
Xi'an
Zip:
710065
Country:
China
Status:
Recruiting
Contact:
Last name:
Zheng Wang, PhD
Phone:
+8615902993665
Email:
zheng.wang11@mail.xjtu.edu.cn
Contact backup:
Last name:
Liang Han, PhD
Phone:
+8613379181359
Email:
hanliangxjtu@163.com
Start date:
May 6, 2024
Completion date:
March 2028
Lead sponsor:
Agency:
Health Science Center of Xi'an Jiaotong University
Agency class:
Other
Collaborator:
Agency:
LinkDoc Technology (Beijing) Co. Ltd.
Agency class:
Industry
Collaborator:
Agency:
Huazhong University of Science and Technology
Agency class:
Other
Source:
Health Science Center of Xi'an Jiaotong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06368063
