Clinical trial · Interventional
Clinical Study of Huaier Granule in the Treatment of Unresectable Pancreatic Cancer
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
NCT06387368CI-TRIAL-00076559not yet recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer Non-resectable | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Huaier Granule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Huaier treatment group
- description
- 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.
- interventionNames
- Drug: Huaier Granule
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- 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.
- interventionNames
- Drug: Capecitabine
Primary outcomes (1)
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.