Clinical trial NCT06368063: The Study of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer
Official title: Study on the Efficacy and Safety of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pancreatic Cancer Resectable
Keywords: Huaier granule
Postoperative adjuvant therapy
Resectable pancreatic cancer
Efficacy and safety
Lead sponsor: Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: LinkDoc Technology (Beijing) Co. Ltd.
name: Huazhong University of Science and Technology
First posted: 2024-04-16
Enrollment: 642
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Primary outcomes:
measure: Disease-free survival
timeFrame: Start of treatment until 2-year follow-up
Secondary outcomes:
measure: Overall survival
timeFrame: Start of treatment until 2-year follow-up
measure: Progression-free survival
timeFrame: Start of treatment until 2-year follow-up
measure: The incidence and severity of adverse events (AE) and severe adverse events (SAE)
timeFrame: Start of treatment until 2-year follow-up
measure: The incidence and severity of ADR, severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR)
timeFrame: Start of treatment until 2-year follow-up
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Zheng Wang
state: Shannxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Zheng Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: