A prospective, randomized and controlled clinical study of traditional Chinese medicine (Astragalus / Panax notoginseng) combined with a new oncolytic virus / fusion cell vaccine in the treatment of advanced liver cancer and lung cancer

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional study

Sex

All

Sponsor

•Inclusion criteria of liver cancer
•1\) The age is from 18 to 75 years old, gender is not limited;
•2\) Late stage HCC (non operative or metastatic) confirmed by histology / cytology and lack of criteria patients who are treated or do not have standard treatment conditions;
•3\) Child Pugh liver function rating: A, B;
•4\) There is at least one measurable focus (according to the recist1\.1 standard);
•5\) At least 4 weeks or more than 5 half\-lives after the last anti\-tumor treatment; surgical treatment more than 3 months; the end time of the last interventional therapy was more than 1 month;
•6\) Expected survival time \>\= 3 months;
•7\) The MELD score was less than 9;
•8\) Can cooperate to observe adverse events and curative effect;
•9\) No other anti\-tumor concomitant treatment (including steroid drugs);

•Exclusion criteria for liver cancer
•1\) Severe cirrhosis, liver atrophy, portal hypertension, ascites of medium or more quantity;
•2\) Previous history of liver transplantation;
•3\) Diffuse liver cancer, tumor thrombus or liver obstructive jaundice in the main portal vein, and liver failure, it is difficult to control hepatic encephalopathy;
•4\) Double cancer and multiple cancer patients;
•5\) Active upper gastrointestinal ulcer, obvious vomiting, chronic diarrhea, intestinal obstruction, absorption disorder , etc.. Other patients known to affect drug absorption, distribution, metabolism or clearance;
•6\) The toxicity of previous anticancer therapy has not been restored to level I or completely recovered from previous surgery;
•7\) Active bleeding or abnormal coagulation (PT \> 16S, APTT \> 43S, TT \> 21s, INR \>\= 2\), with bleeding tendency or undergoing thrombolysis or anticoagulation treatment;
•8\) Taking drugs that may prolong QTc and / or TDP or affect drug metabolism (such as sedation agent) at the same time;
•9\) Suspected allergy to Astragalus / Panax notoginseng, oncolytic virus or similar drugs and their metabolites or their pharmaceutical accessories;

Not specified