Pancreatic Cancer ResectablePhase 4NCT06368063
The Study of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer
A Phase 4 study testing Huaier granule and chemotherapy drugs in people with Pancreatic Cancer Resectable, run by Xi'an Jiaotong University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer Resectable
- What is being tested?
- Huaier granule and chemotherapy drugs
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 642 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2024to Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zheng Wang
Xi'an, Shannxi, 710065
Zheng Wang, PhD, +8615902993665, zheng.wang11@mail.xjtu.edu.cn
Liang Han, PhD, +8613379181359, hanliangxjtu@163.com
About this study
Official title: Study on the Efficacy and Safety of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer
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
Read the 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.
- Conditions
- Pancreatic Cancer Resectable
- Being tested
- Huaier granule, chemotherapy drugs
- Keywords
- Huaier granule, Postoperative adjuvant therapy, Resectable pancreatic cancer, Efficacy and safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huaier granuleDrug
Also called Z20000109#NMPA Approval Number#
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.
chemotherapy drugsDrug
Also called Standard chemotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Huaier treatment group | Experimental | The subjects take Huaier granules orally and start taking them within 15-30 days after surgery until the end of the study, intolerable toxicity occurs, withdrawal from the study for any reason, or death, whichever occurs first; Or the researcher determines that the subjects no longer benefit. Receives: Drug: Huaier granule |
| Standard chemotherapy group | Active comparator | Accept treatment with Class 1A chemotherapy drugs recommended by CSCO (choose any one to receive treatment)
* Gemcitabine combine with capecitabine
* mFOLFIRINOX solution
* Gemcitabine monotherapy
* Tegafur，gimeracil and oteracil potassium capsules monotherapy Receives: Drug: chemotherapy drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
It is defined as the time from the first day after radical resection of pancreatic cancer to recurrence or all-cause death of pancreatic cancer.
Measured: Start of treatment until 2-year follow-up
Secondary outcomes (4)
Overall survival
It is defined as the time between the start date of enrollment and the recorded date of all-cause death. For subjects who were lost to follow-up before death, the last follow-up time is usually calculated as the time of death.
Measured: Start of treatment until 2-year follow-up
Progression-free survival
It is defined as the time between the start date of enrollment and the date of imaging progression or all-cause death evaluated by the investigator.
Measured: Start of treatment until 2-year follow-up
The incidence and severity of adverse events (AE) and severe adverse events (SAE)
The definitions and severity grading of AE and SAE refer to the corresponding descriptions in the definition and evaluation section of AE. The incidence rate is defined as the proportion of patients with AE and SAE to the corresponding total population.
Measured: Start of treatment until 2-year follow-up
The incidence and severity of ADR, severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR)
The definitions and severity grading of ADR, severe ADR, and SUSAR refer to the corresponding descriptions in the definition and evaluation section of AE. The incidence rate is defined as the proportion of patients with ADR, severe ADR, and SUSAR to the corresponding total population.
Measured: Start of treatment until 2-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start6 May 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer ResectableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 642 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd., Huazhong University of Science and Technology
- Responsible party
- Principal investigator, Zheng Wang, Xi'an Jiaotong University
- Investigators
- Zheng Wang, PhD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368063
- Sponsor's protocol ID
- HE-202301
- Status last verified
- May 2024
- First submitted
- 11 Apr 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Safety of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06368063
- Acronym / sponsor ID
- HE-202301
- Conditions
- Pancreatic Cancer Resectable
- Keywords
- Huaier granule, Postoperative adjuvant therapy, Resectable pancreatic cancer, Efficacy and safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 642 participants (estimated)
- Lead sponsor
- Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd., Huazhong University of Science and Technology
- Study start
- 6 May 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Huaier treatment group | Experimental | Drug: Huaier granuleThe subjects take Huaier granules orally and start taking them within 15-30 days after surgery until the end of the study, intolerable toxicity occurs, withdrawal from the study for any reason, or death, whichever occurs first; Or the researcher determines that the subjects no longer benefit. |
| Standard chemotherapy group | Active comparator | Drug: chemotherapy drugsAccept treatment with Class 1A chemotherapy drugs recommended by CSCO (choose any one to receive treatment) * Gemcitabine combine with capecitabine * mFOLFIRINOX solution * Gemcitabine monotherapy * Tegafur，gimeracil and oteracil potassium capsules monotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Huaier granuleAlso: Z20000109#NMPA Approval Number#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. | Drug | Huaier treatment group |
| chemotherapy drugsAlso: Standard chemotherapyAccept 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. | Drug | Standard chemotherapy group |
Primary outcome
Disease-free survival
Time frame: Start of treatment until 2-year follow-up
It is defined as the time from the first day after radical resection of pancreatic cancer to recurrence or all-cause death of pancreatic cancer.
4 secondary outcomes
Overall survival
Time frame: Start of treatment until 2-year follow-up
Progression-free survival
Time frame: Start of treatment until 2-year follow-up
The incidence and severity of adverse events (AE) and severe adverse events (SAE)
Time frame: Start of treatment until 2-year follow-up
The incidence and severity of ADR, severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR)
Time frame: Start of treatment until 2-year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zheng Wang, PhD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Huaier granule and chemotherapy drugs in people with Pancreatic Cancer Resectable, run by Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zheng Wang, PhD (+8615902993665, zheng.wang11@mail.xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: Start of treatment until 2-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.