ITMCTR2000003215招募中1 期
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
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研究概览
简要总结
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研究设计
- 研究类型
- Interventional study
入排标准
- 性别
- All
入选标准
- •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 <= 2;
- •11) Serum albumin >= 30g / L, ALT <= 190u / L, AST <= 200u / L, serum TBIL <= 1.5 x ULN, electrolyte normal or normal after treatment, proteinuria = 0 ~ 1 +, blood creatinine <= 1.5 × ULN;
- •12) The blood routine examination standard should be: HB >= 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 <= 1.5 x ULN, ALT and Ast <= 2.5 x ULN, ALT or AST <= 5 x ULN in case of liver metastasis; Normal renal function: creatinine <= 1.5 x ULN or creatinine clearance rate >= 60 ml / min in 24 hours; Coagulation function is basically normal: INR <= 1.5 x ULN, APTT <= 1.5 x ULN; Cardiac function: left ventricular ejection fraction >= 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);
排除标准
- •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 < 60ml / min, serum creatinine
- •>= 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
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