Investigating the Efficacy and Safety of the Combination Treatment of Huaier Granule and Biliary Drainage for MOJ

• Conditions: Obstructive Jaundice

• Registration Number: NCT03491254
• Lead Sponsor: zhaoyu liu

Brief Summary

This study is designed to evaluate the efficacy and safety of the combination treatment of Huaier granule and biliary drainage for malignant obstructive jaundice.

Detailed Description

After sign the informed consent, the, eligible patients are those who have completed the examinations within 2 weeks after the biliary drainage will enter the study and visit the study sites at Weeks 12, 24, 36, and 48. The follow-up duration is up to 48 weeks or until the death of patient during the study. The patients will be allocated to two groups based on whether being exposed to Huaier granule or not.

Study data will be collected prospectively, including the patients' baseline characteristics, chemo-/radio-therapy history, previous Huaier granule treatment, laboratory tests, imaging examinations, and various clinical endpoints including liver function, quality of life, status of survival, and safety.

This is a non-interventional study in patient population in real world. Therefore, the patients' treatment regimen will not be interfered, i.e., the patients will independently decide whether to take Huaier granule or not based on the recommendation from the clinician after the drainage. The patients will be allocated into different groups completely according to their treatment at clinic in real world. During the study, only the study required data and endpoints will be collected.

Study Timeline

• Study First Submitted: 2018-03-22
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-05
• Study First Posted: 2018-04-09
• Last Update Submitted: 2018-04-20
• Last Update Posted: 2018-04-24
• Study Start: 2018-05-30
• Primary Completion: 2020-11-30
• Study Completion: 2021-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 852

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	every 12 weeks until death, up to 48 weeks	the time interval between baseline and the time of death due to any cause

Secondary Outcome Measures

Name	Time	Method
overall survival rate	48 weeks	Overall survival rate at 48 weeks was defined as the proportion of patients who were alive at 48 weeks
Median survival time (MST)	48 weeks	indicate the survival time when only 50% of patients are still alive.
Karnofsky (KPS) score	48 weeks	improved is defined as KPS increases \>10 after treatment; worsen is defined as KPS decreases \>10; stable is defined as KPS changes ≤10.
Liver function 1	12、24、36、48 weeks	Measurement of direct bilirubin
Liver function 2	12、24、36、48 weeks	Measurement of total bilirubin
Liver function 3	12、24、36、48 weeks	the time of reoccurrence of jaundice.
Quality of Life (QoL) score	48 weeks	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.
Adverse Events	12、24、36、48 weeks	Incidence rate of Adverse events