UnknownNot Applicable

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

852 participantsStarted 2018-05-30

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Male or female, aged between 18\~75 years;
✓. 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;
✓. Total bilirubin \>80 umol/L;
✓. Patients who are not indicated for or refused to receive surgical resection;
✓. ECOG score ≤2 or KPS score ≥60;
✓. Expected survival time ≥12 weeks;
✓. Has signed and dated the informed consent in volunteer and are willing to comply with the data collection procedures by Investigator.

Exclusion criteria

✕. Female patients who are pregnant or breastfeeding;
✕. Patients who are receiving concomitant intravenous chemotherapy;
✕. Patients whose malignant obstructive jaundice was caused by liver cancer;
✕. Patients who have severe coagulation disorders and massive ascites;
✕. Patients with obstructive jaundice who have concomitant fever;
✕. Patients who are not applicable for or not willing to receive biliary drainage;
✕. Patients who are not appropriate to participate in the study at discretion of the Investigator.

What they're measuring

Overall survival

Timeframe: every 12 weeks until death, up to 48 weeks

Trial details

NCT IDNCT03491254

Sponsorzhaoyu liu

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-11-30

Contact for this trial

zhaoyu liu, Professor

+0086-18940251226 liuzhaoyu001@sina.com

View on ClinicalTrials.gov More Obstructive Jaundice trials