Obstructive Jaundice Clinical Trial
Official title:
A Multisite, Open-label, Prospective Cohort Study Investigating Huaier Granule Combined With Biliary Drainage for Treatment of Malignant Obstructive Jaundice(MOJ)
This study is designed to evaluate the efficacy and safety of the combination treatment of Huaier granule and biliary drainage for malignant obstructive jaundice.
Status | Not yet recruiting |
Enrollment | 852 |
Est. completion date | May 31, 2021 |
Est. primary completion date | November 30, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Male or female, aged between 18~75 years; 2. Naïve patients who were diagnosed as malignant obstructive jaundice that was caused by carcinoma of head of pancreas, cholangiocarcinoma, gallbladder carcinoma, or duodenal papilla carcinoma, or carcinoma metastasis in hilar lymph nodes based on clinical assessments and/or pathological examination; 3. Total bilirubin >80 umol/L; 4. Patients who are not indicated for or refused to receive surgical resection; 5. ECOG score =2 or KPS score =60; 6. Expected survival time =12 weeks; 7. Has signed and dated the informed consent in volunteer and are willing to comply with the data collection procedures by Investigator. Exclusion Criteria: 1. Female patients who are pregnant or breastfeeding; 2. Patients who are receiving concomitant intravenous chemotherapy; 3. Patients whose malignant obstructive jaundice was caused by liver cancer; 4. Patients who have severe coagulation disorders and massive ascites; 5. Patients with obstructive jaundice who have concomitant fever; 6. Patients who are not applicable for or not willing to receive biliary drainage; 7. Patients who are not appropriate to participate in the study at discretion of the Investigator. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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zhaoyu liu |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | the time interval between baseline and the time of death due to any cause | every 12 weeks until death, up to 48 weeks | |
Secondary | overall survival rate | Overall survival rate at 48 weeks was defined as the proportion of patients who were alive at 48 weeks | 48 weeks | |
Secondary | Median survival time (MST) | indicate the survival time when only 50% of patients are still alive. | 48 weeks | |
Secondary | Karnofsky (KPS) score | improved is defined as KPS increases >10 after treatment; worsen is defined as KPS decreases >10; stable is defined as KPS changes =10. | 48 weeks | |
Secondary | Liver function 1 | Measurement of direct bilirubin | 12?24?36?48 weeks | |
Secondary | Liver function 2 | Measurement of total bilirubin | 12?24?36?48 weeks | |
Secondary | Liver function 3 | the time of reoccurrence of jaundice. | 12?24?36?48 weeks | |
Secondary | Quality of Life (QoL) score | Quality of Life (QOL) were measured using supplemental quality of life questions. Item score range(12 items): 1(worst symptom) to 5 (no symptom). Change: score at 48 weeks minus score at baseline. | 48 weeks | |
Secondary | Adverse Events | Incidence rate of Adverse events | 12?24?36?48 weeks |
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