Actively Recruiting
Study on the Efficacy and Safety of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer
Led by Xi'an Jiaotong University · Updated on 2024-05-08
642
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
X
Xi'an Jiaotong University
Lead Sponsor
L
LinkDoc Technology (Beijing) Co. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of Huaier Granule as a postoperative adjuvant treatment for patients with resectable pancreatic cancer. This multicenter, prospective clinical study includes individuals who have undergone radical tumor resection and have been pathologically diagnosed with pancreatic adenocarcinoma. The study compares Huaier Granule treatment with standard chemotherapy regimens recommended by the 2022 CSCO guidelines. Participants are divided into two groups: one receiving standard chemotherapy, which includes options like gemcitabine combined with capecitabine, mFOLFIRINOX, gemcitabine monotherapy, or tegafur capsules; and the other receiving Huaier Granules orally, starting 15-30 days after surgery. Huaier is taken as 10g three times daily until the study ends, intolerable side effects occur, withdrawal, death, or the researcher decides there is no further benefit. During the study, participants will be monitored through regular follow-up visits for up to two years, tracking disease-free survival as the primary outcome. Researchers will also assess overall survival, progression-free survival, and the incidence and severity of adverse events and adverse drug reactions. The study aims to gather comprehensive data on treatment outcomes and safety over this period.
CONDITIONS
Brief Title
The Study of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age range from 18 to 80 years old, regardless of gender
- Pancreatic cancer diagnosed by histopathology after radical surgery within 12 weeks before enrollment
- No neoadjuvant therapy before surgery and no adjuvant therapy after surgery
- ECOG performance status score between 0 and 3
- Voluntarily choose either standard chemotherapy or Huaier granules for postoperative adjuvant treatment and agree to participate in all research activities
- Signed written informed consent before participation
You will not qualify if you...
- Known allergy to Huaier granule components or caution advised in its use (for Huaier group)
- Inability to take oral medication due to active gastrointestinal bleeding, perforation, gastric paralysis, or similar conditions
- Serious mental illness or other conditions deemed unsuitable by the researcher
- History of other malignant tumors
- Concomitant myocardial infarction, cerebral infarction, or thromboembolic diseases requiring surgery
- Severe infections
- Child Pugh C-grade liver function or renal function grades 2 to 5 with glomerular filtration rate less than 90 ml/min
- Pregnant or breastfeeding women or those planning pregnancy
- Use of other traditional Chinese anti-tumor medicines, chemotherapy, or physical therapy within 4 weeks prior to enrollment (including compound cantharidin capsules, cinobufotalin capsules, Kangai injection)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive postoperative adjuvant therapy either by taking Huaier granules orally starting 15 to 30 days after surgery until intolerable toxicity, withdrawal, death, or determined no longer beneficial; or by receiving Class 1A chemotherapy regimens as per guidelines for up to 6 months.
Visits occur according to treatment schedule, including oral medication or intravenous chemotherapy infusions
Duration - Up to 2 years
Participants are monitored for disease-free survival, overall survival, progression-free survival, and adverse events for up to 2 years after treatment starts.
Regular follow-up visits during the 2-year period
Trial Site Locations
Total: 1 location
1
Zheng Wang
Xi'an, Shannxi, China, 710065
Actively Recruiting
Research Team
Z
Zheng Wang, PhD
L
Liang Han, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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