Evaluating Huaier Granule for Postoperative Treatment of Pancreatic Cancer
Study on the Efficacy and Safety of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer
This study is testing if Huaier Granule can help people with pancreatic cancer feel better after surgery compared to standard chemotherapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 642 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Xi'an Jiaotong University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Xi'an, Shannxi) |
| Trial ID | NCT06368063 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective clinical study aims to assess the efficacy and safety of Huaier Granule as a postoperative adjuvant treatment for patients with resectable pancreatic cancer. Participants will be divided into two groups: one receiving standard chemotherapy and the other receiving Huaier Granule exclusively. The study plans to enroll at least 642 subjects who have undergone radical tumor resection and have been diagnosed with pancreatic adenocarcinoma. The trial will take place from April 2024 to March 2026 across selected research centers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who have undergone radical surgery for pancreatic cancer and have not received prior neoadjuvant or adjuvant therapy.
Not a fit: Patients who are allergic to Huaier granules or have difficulty taking oral medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel adjuvant therapy option for patients recovering from pancreatic cancer surgery.
How similar studies have performed: While the use of Huaier Granule in this context is novel, similar studies exploring alternative adjuvant therapies have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Xi'an, Shannxi
- Zheng Wang — Xi'an, Shannxi, China (Recruiting)
Study contacts
- Principal investigator: Zheng Wang, PhD — First Affiliated Hospital Xi'an Jiaotong University
- Study coordinator: Zheng Wang, PhD
- Email: zheng.wang11@mail.xjtu.edu.cn
- Phone: +8615902993665
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.