Clinical trial NCT03491254: Investigating the Efficacy and Safety of the Combination Treatment of Huaier Granule and Biliary Drainage for MOJ
Official title: A Multisite, Open-label, Prospective Cohort Study Investigating Huaier Granule Combined With Biliary Drainage for Treatment of Malignant Obstructive Jaundice（MOJ）
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Jaundice
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 852
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with malignant obstructive jaundice

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: every 12 weeks until death, up to 48 weeks
Secondary outcomes:
measure: overall survival rate
timeFrame: 48 weeks
measure: Median survival time (MST)
timeFrame: 48 weeks
measure: Karnofsky (KPS) score
timeFrame: 48 weeks
measure: Liver function 1
timeFrame: 12、24、36、48 weeks
measure: Liver function 2
timeFrame: 12、24、36、48 weeks
measure: Liver function 3
timeFrame: 12、24、36、48 weeks
measure: Quality of Life (QoL) score
timeFrame: 48 weeks
measure: Adverse Events
timeFrame: 12、24、36、48 weeks
Other outcomes:
Locations:
Study officials:
References: