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

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.

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 852

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with malignant obstructive jaundice

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group A/exposure group; Huaier Granule & biliary drainage
Group B/non-exposure group; biliary drainage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival rate	Overall survival rate at 48 weeks was defined as the proportion of patients who were alive at 48 weeks	48 weeks
Median survival time (MST)	indicate the survival time when only 50% of patients are still alive.	48 weeks
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
Liver function 1	Measurement of direct bilirubin	12、24、36、48 weeks
Liver function 2	Measurement of total bilirubin	12、24、36、48 weeks
Liver function 3	the time of reoccurrence of jaundice.	12、24、36、48 weeks
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
Adverse Events	Incidence rate of Adverse events	12、24、36、48 weeks

Collaborators and Investigators

• Sponsor: zhaoyu liu

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 30, 2018
• Primary Completion (ANTICIPATED): November 30, 2020
• Study Completion (ANTICIPATED): May 31, 2021

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (ACTUAL): April 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 20, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Manifestations; Hyperbilirubinemia; Jaundice; Jaundice, Obstructive
• Other Study ID Numbers: HE-201801

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No