Lung cancer, liver cancer\Various malignant tumors
Conditions
Interventions
Group 4:Traditional Chinese medicine agreement, radiotherapy / chemotherapy / targeted treatment and Astragalus / Panax notoginseng and new oncolytic virus
Group 3:Traditional Chinese medicine agreement, radiotherapy / chemotherapy / targeted treatment and fusion cell vaccine
Group 6:Traditional Chinese medicine agreement, radiotherapy / chemotherapy / targeted treatment, Astragalus / Panax notoginseng, new oncolytic virus and fusion cell vaccine
Group 1:Traditional Chinese medicine agreement, radiotherapy / chemotherapy / targeted treatment
Group 2:Traditional Chinese medicine agreement, radiotherapy / chemotherapy / targeted therapy and new oncolytic virus
Group 5:Traditional Chinese medicine agreement, radiotherapy / chemotherapy / targeted treatment, Astragalus / Panax notoginseng and fusion cell vaccine
Sponsors
The First Affiliated Hospital of Guangxi University of traditional Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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); 10) ECoG score = 30g / L, ALT = 80g / L; ANC >= 1.5 x 10^9 / L; PLT >= 70 x 10^9/L; 13) Patients voluntarily sign written informed consent. Inclusion criteria of lung cancer 1) Voluntarily participate in the clinical trial, understand the research procedure and have signed the informed consent; 2) Age: male or female patients aged 18-75 years; 3) Patients with locally advanced or metastatic small cell or non-small cell lung cancer confirmed by histology or cytology; 4) According to the standard of ECoG, the physical condition was 0-2 points; 5) The expected life span is not less than 3 months; 6) According to recist1.1 evaluation standard of solid tumor efficacy, patients have at least one imaging (CT, MRI) can measure the focus, the longest diameter is required to be >= 10 mm (in case of lymph nodes, the short axis is required to be >= 15 mm) (brain metastasis is not the only measurable lesion); 7) The subjects must have proper organ function and meet the following laboratory test results before entering the group: Bone marrow reserve is basically normal: neutrophil absolute count >= 1.5 x 10^9 / L, platelet >= 100 x 10^9 / L, and hemoglobin >= 80g / L; Liver function is basically normal: albumin in serum >= 3.0 g / dl; bilirubin = 60 ml / min in 24 hours; Coagulation function is basically normal: INR = 50%; ECG is basically normal, QT interval in men <= 450 ms, female <= 470 MS; 8) The patient must recover from the previous treatment toxicity to <= level 1, except for alopecia and previous platinum containing treatment of level 2 related neuropathy (CTC AE 5.0);
Exclusion criteria
Exclusion criteria: 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; 10) Pregnant or lactating women, or those who are unwilling to use contraception during the trial; 11) Any significant clinical and laboratory abnormalities that the investigator considers to affect the safety assessment; 12) Brain metastasis, meningeal metastasis or various mental disorders; 13) Glomerular filtration rate was significantly abnormal (creatinine clearance rate = 1.5 x ULN); 14) They are receiving broad-spectrum antiviral drugs, such as amantadine, acyclovir, ganciclovir and lidocaine bavelin, et al. 3 days of discontinuation of Antihepatitis B treatment; 15) Autoimmune diseases; 16) HIV, HCV, HDV infection; 17) Those who participated in clinical trials of any drugs or medical devices within 3 months before the trial. Exclusion criteria for lung cancer 1) Those who have a history of allergy to Astragalus / notoginseng and their metabolites or their pharmaceutical excipients (with or without activity); 2) Have taken other drugs in clinical trials within 30 days before the first administration; 3) In addition to lung cancer, in the past five years, there has been a diagnosis of another kind of malignant tumor (excluding those already treated malignant tumors, such as completely resected basal cell carcinoma and carcinoma in situ; 4) Major surgical treatment, open biopsy or significant trauma within 2 weeks prior to first use of study drug. In all cases, the patient must be fully recovered and stable before treatment; 5) Subjects with active gastrointestinal disease or other diseases may significantly affect drug absorption, metabolic or excretory factors; 6) Uncontrollable chronic systemic complications (such as severe chronic lung, liver, kidney, heart or visceral diseases); 7) According to NYHA standard, patients with grade III-IV cardiac insufficiency; 8) QTc of baseline ECG was prolonged (QTCF: male > 450 ms, female > 470 MS); 9) Any uncontrollable serious clinical research related problems (such as uncontrolled psychosis state, uncontrolled pleural effusion and / or pericardial effusion, uncontrolled complications, including mobility infection, arterial thrombosis and symptomatic pulmonary embolism; 10) Presence of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring steroid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety index; | — |
Secondary
| Measure | Time frame |
|---|---|
| TTP;DCR;Symptom relief rate;Quality of life;ORR; | — |
Countries
China
Contacts
Public ContactWei Shi
The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine
Outcome results
None listed