Pancreatic Cancer Non-resectablePhase 4NCT06387368
Clinical Study of Huaier Granule in the Treatment of Unresectable Pancreatic Cancer
A Phase 4 study testing Huaier Granule and Capecitabine in people with Pancreatic Cancer Non-resectable, run by Xi'an Jiaotong University.
Trial summary
This is a prospective, multicenter, randomized, open, parallel controlled clinical study to evaluate the efficacy and safety of Huaier Granules combined with capecitabine in the treatment of unresectable pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer Non-resectable
- What is being tested?
- Huaier Granule and Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, regardless of gender.
- The patient has a clear evaluable lesion (RECIST 1.1) and is diagnosed with pancreatic adenocarcinoma through tissue or cellular pathology. Clinical evaluation suggests that radical surgical resection cannot be performed (due to jaundice and gastrointestinal obstruction caused by tumor compression, stent treatment or normal inclusion of biliary and gastrointestinal anastomosis can be performed).
- Patients voluntarily give up conversion therapy, local radiation therapy, targeted immunity, and other programs.
- The patient voluntarily choose chemotherapy, and the plan is to take capecitabine monotherapy orally.
- ECOG score 0-3 points.
- The patients voluntarily participate in and cooperates with all aspects of the research, including but not limited to cooperating with treatment and follow-up, cooperating with the researcher in data collection, not actively taking other treatments, and signing a written informed consent form.
Who cannot join
- Known to be allergic to the components of Huaier granules or to avoid or use Huaier granules with caution (Huaier group).
- Patients with difficulty swallowing, complete or incomplete gastrointestinal obstruction (excluding those who have undergone gastrointestinal stenting or diversion surgery due to tumor related gastrointestinal obstruction and have a normal diet, can be included in the study normally), active gastrointestinal bleeding, perforation, and other oral medication difficulties.
- After actively reducing jaundice (including but not limited to bile duct/gallbladder puncture external drainage, nasobiliary duct external drainage, biliary stent internal drainage, biliary intestinal anastomosis internal drainage, etc.), the levels of aspartate aminotransferase, alanine aminotransferase, or total bilirubin are still 2.5 times higher than the upper limit of normal values.
- 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).
- Suffering from serious mental illness or other reasons that the researcher deems unsuitable to participate in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective, Multicenter, Randomized, Parallel Controlled Clinical Study on the Efficacy and Safety of Huaier Granules Combined With Capecitabine Versus Capecitabine Alone in the Treatment of Unresectable Pancreatic Cancer
This is a prospective, multicenter, randomized, open, parallel controlled clinical study to evaluate the efficacy and safety of Huaier Granules combined with capecitabine in the treatment of unresectable pancreatic cancer.
Read the detailed description
This study is a prospective, multicenter, randomized, open label, parallel controlled clinical study. It is expected to include approximately 488 patients diagnosed with unresectable pancreatic adenocarcinoma by tissue or cellular pathology who visited the selected research center from April 2024 to March 2026. The treatment regimen will be capecitabine monotherapy orally. Among them, the Huaier group uses "capecitabine+Huaier granules", and is expected to include 244 cases; The control group received capecitabine and is expected to include 244 cases.
- Conditions
- Pancreatic Cancer Non-resectable
- Being tested
- Huaier Granule, Capecitabine
- Keywords
- Huaier Granules, Capecitabine, Unresectable 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. Capecitabine: oral administration, 1250mg/m^2, twice a day (2500mg/m^2/d), day 1-14, once every 3 weeks.
CapecitabineDrug
Also called Standard chemotherapy
Oral administration, 1250mg/m^2, twice a day (2500mg/m^2/d), day 1-14, once every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Huaier treatment group | Experimental | The subjects received a combination of Huaier granules and capecitabine regimen.The subject takes Huaier granules orally, 10g once, three times a day; take capecitabine 1250mg/m^2 orally , twice a day (2500mg/m^2/d), day 1-14, once every 3 weeks. Receives: Drug: Huaier Granule |
| Control group | Active comparator | The subjects received the capecitabine monotherapy regimen. The subjects take capecitabine orally, 1250mg/m^2, twice a day (2500mg/m^2/d), day for 1-14 days, once every 3 weeks. Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
It is defined as the time from the day of patient randomization to death due to any reason.
Measured: Start of treatment until 2-year follow-up
Secondary outcomes (5)
Objective response rate
It is defined as the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, generally understood as the sum of CR and PR(CR ,complete remission ,all target lesions disappear, maintained for 4 weeks; PR ,partial remission ,it is defined as a reduction of at least 30% in the sum of the longest diameters of the target lesion compared to baseline, maintained for 4 weeks).
Measured: Start of treatment until 2-year follow-up
Progression free survival
It is defined as the period between the start of treatment and the observation of disease progression or death due to any reason for patients with pancreatic cancer in this study.
Measured: Start of treatment until 2-year follow-up
Conversion surgery rate
It is defined as the proportion of patients diagnosed as locally advanced pancreatic cancer before surgery (stage III) who can accept radical surgery after clinical evaluation; The proportion of patients with oligometastatic lesions (belonging to stage IV) who have no new lesions and significant regression of the metastatic lesions after treatment, and whose primary lesions can be removed (regardless of whether they can be removed before treatment) are clinically assessed as eligible for radical surgery.
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 posted29 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionAug 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 Non-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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 488 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
- NCT06387368
- Sponsor's protocol ID
- HE-202303
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 29 Apr 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 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized, Parallel Controlled Clinical Study on the Efficacy and Safety of Huaier Granules Combined With Capecitabine Versus Capecitabine Alone in the Treatment of Unresectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06387368
- Acronym / sponsor ID
- HE-202303
- Conditions
- Pancreatic Cancer Non-resectable
- Keywords
- Huaier Granules, Capecitabine, Unresectable Pancreatic Cancer, Efficacy and Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 488 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
- May 2024 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 29 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.
This is a prospective, multicenter, randomized, open, parallel controlled clinical study to evaluate the efficacy and safety of Huaier Granules combined with capecitabine in the treatment of unresectable pancreatic cancer.
Detailed description
This study is a prospective, multicenter, randomized, open label, parallel controlled clinical study. It is expected to include approximately 488 patients diagnosed with unresectable pancreatic adenocarcinoma by tissue or cellular pathology who visited the selected research center from April 2024 to March 2026. The treatment regimen will be capecitabine monotherapy orally. Among them, the Huaier group uses "capecitabine+Huaier granules", and is expected to include 244 cases; The control group received capecitabine and is expected to include 244 cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Huaier treatment group | Experimental | Drug: Huaier GranuleThe subjects received a combination of Huaier granules and capecitabine regimen.The subject takes Huaier granules orally, 10g once, three times a day; take capecitabine 1250mg/m^2 orally , twice a day (2500mg/m^2/d), day 1-14, once every 3 weeks. |
| Control group | Active comparator | Drug: CapecitabineThe subjects received the capecitabine monotherapy regimen. The subjects take capecitabine orally, 1250mg/m^2, twice a day (2500mg/m^2/d), day for 1-14 days, once every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years old, regardless of gender.
- The patient has a clear evaluable lesion (RECIST 1.1) and is diagnosed with pancreatic adenocarcinoma through tissue or cellular pathology. Clinical evaluation suggests that radical surgical resection cannot be performed (due to jaundice and gastrointestinal obstruction caused by tumor compression, stent treatment or normal inclusion of biliary and gastrointestinal anastomosis can be performed).
- Patients voluntarily give up conversion therapy, local radiation therapy, targeted immunity, and other programs.
- The patient voluntarily choose chemotherapy, and the plan is to take capecitabine monotherapy orally.
- ECOG score 0-3 points.
Key exclusion criteria (10 listed)
- Known to be allergic to the components of Huaier granules or to avoid or use Huaier granules with caution (Huaier group).
- Patients with difficulty swallowing, complete or incomplete gastrointestinal obstruction (excluding those who have undergone gastrointestinal stenting or diversion surgery due to tumor related gastrointestinal obstruction and have a normal diet, can be included in the study normally), active gastrointestinal bleeding, perforation, and other oral medication difficulties.
- After actively reducing jaundice (including but not limited to bile duct/gallbladder puncture external drainage, nasobiliary duct external drainage, biliary stent internal drainage, biliary intestinal anastomosis internal drainage, etc.), the levels of aspartate aminotransferase, alanine aminotransferase, or total bilirubin are still 2.5 times higher than the upper limit of normal values.
- 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. Capecitabine: oral administration, 1250mg/m^2, twice a day (2500mg/m^2/d), day 1-14, once every 3 weeks. | Drug | Huaier treatment group |
| CapecitabineAlso: Standard chemotherapyOral administration, 1250mg/m^2, twice a day (2500mg/m^2/d), day 1-14, once every 3 weeks. | Drug | Control group |
Primary outcome
Overall survival
Time frame: Start of treatment until 2-year follow-up
It is defined as the time from the day of patient randomization to death due to any reason.
5 secondary outcomes
Objective response rate
Time frame: Start of treatment until 2-year follow-up
Progression free survival
Time frame: Start of treatment until 2-year follow-up
Conversion surgery rate
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 29 Apr 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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Huaier Granule and Capecitabine in people with Pancreatic Cancer Non-resectable, run by Xi'an Jiaotong University.
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 10 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: opening soon, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Overall 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 29 Apr 2024.