Various malignant tumors
Conditions
Interventions
1:Oncolytic virus + Anlotinib
2:Oncolytic virus
3:Anlotinib
Sponsors
The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for liver cancer 1) 18 to 75 years old, regardless of gender; 2) Patients with advanced hepatocellular carcinoma (inoperable or metastatic) diagnosed by histology/cytology and imaging and lack of standard treatment or do not have standard treatment conditions; 3) Child-pugh liver function rating: Grade A, Grade B; 4) PET-CT examination at least one measurable lesion (according to RECIST1.1 standard); 5) Before enrollment, patients received at least 4 weeks or more than 5 half-lives after the last anti-tumor treatment; more than 1 month after palliative surgery; 6) Expected survival time >= 3 months; 7) End-stage liver disease model (MELD) score = 30g/L, serum ALT = 80g/L; ANC >= 1.5 x 10^9/L; PLT >= 70 x 10^9/L; 13) The patient voluntarily signs a written informed consent. Inclusion criteria for lung cancer 1) Volunteer to participate in this clinical trial, understand the research procedures and have signed informed consent; 2) Age: 18~75 years old male or female patients; 3) Pathological and imaging diagnosis of patients with advanced lung cancer; 4) According to the Eastern Cooperative Oncology (ECOG) standard, the physical status is 0~2 points; 5) Expected survival period is not less than 3 months; 6) According to the RECIST 1.1 version of the solid tumor efficacy evaluation standard, the patient has at least one PET-CT measurable lesion with the longest diameter >= 10 mm (if it is a lymph node, the short axis >= 15 mm) (brain metastasis is not the only possible lesion Measure lesions); 7) Subjects must have appropriate organ functions and meet the following laboratory test results before entry: bone marrow reserves are basically normal: absolute neutrophil count >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L, and hemoglobin >= 80g /L; liver function is basically normal: serum albumin >= 3.0 g/dL; bilirubin = 60 mL/min; coagulation function is basically normal: INR = 50% ; ECG is basically normal, QT interval (QTcF) male <= 450 ms, female <= 470 ms; 8) Patients must recover from previous treatment toxicity to <= 1 grade, except for hair loss and grade 2 neuropathy related to previous platinum-containing therapy (CTCAE 5.0); 9) Can cooperate to observe adverse events and curative effects, and perform PET-CT examinations from the beginning to the end of the trial. Inclusion criteria for other malignant solid tumors 1) Volunteer to participate in this clinical trial, understand the research procedures and have signed informed consent; 2) Age: Patients between 18 and 75 years old; 3) Pathologically diagnosed as patients with advanced malignant solid tumors; 4) According to the Eastern Cooperative Oncology (ECOG) standard, the physical status is 0~2 points
Exclusion criteria
Exclusion criteria: Exclusion criteria for liver cancer 1) Severe liver cirrhosis, liver atrophy, portal hypertension, moderate or above ascites; 2) Past medical history of liver transplantation; 3) Diffuse liver cancer, tumor thrombus or hepatic obstructive jaundice in the trunk of the portal vein, liver failure, and uncontrollable hepatic encephalopathy; 4) Patients with double cancer and multiple cancers; 5) Patients with active upper gastrointestinal ulcers, obvious vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc. or other patients who are known to affect drug absorption, distribution, metabolism or clearance; 6) The toxicity of the previous anti-cancer treatment has not recovered to grade I or has not fully recovered from the previous surgery; 7) Active bleeding or abnormal blood coagulation (PT > 16s, APTT > 43s, TT > 21s, INR >= 2), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy; 8) At the same time taking drugs that may prolong QTc and/or Tdp or drugs that affect drug metabolism (such as tranquilizers); 9) Suspected drug and its metabolites or pharmaceutical excipients with a history of allergies; 10) Pregnant or breastfeeding female patients, or those who are unwilling to use contraception during the trial; 11) Any significant clinical and laboratory abnormalities that the investigator believes will affect the safety evaluator; 12) People with brain metastases, meningeal metastases, or various mental disorders; 13) Patients with significantly abnormal glomerular filtration rate (endogenous creatinine clearance rate = 1.5 x ULN); 14) Being treated with broad-spectrum antiviral drugs, such as amantadine, acyclovir, ganciclovir, ribavirin, etc.; anti-hepatitis B virus treatment patients need to stop the drug for 3 days; 15) Autoimmune disease; 16) People infected with HIV, HCV, HDV; 17) Participated in any drug or medical device clinical trial within 3 months before the trial; other anti-tumor drug treatments are in progress. Exclusion criteria for lung cancer: 1) People with a history of allergies to pharmaceutical supplements; 2) Have taken other drugs in clinical trials within 30 days before the first administration, and are undergoing other anti-tumor drug treatments; 3) In addition to lung cancer, people who have been diagnosed with another type of malignant tumor in the past 5 years (excluding cured malignant tumors, such as completely resected basal cell carcinoma and carcinoma in situ); 4) Those who have received major surgical treatment, open biopsy, or obvious traumatic injury within 2 weeks before using the study drug for the first time. In all cases, the patient must fully recover and stabilize before treatment begins; 5) Subjects have active gastrointestinal diseases or other diseases that may cause factors that significantly affect drug absorption, distribution, metabolism or excretion; 6) Uncontrollable chronic systemic complications (such as severe chronic lung, liver, kidney or heart disease); 7) According to NYHA standards, patients with grade III~IV cardiac insufficiency; 8) Patients with prolonged QTc of baseline ECG (QTcF: male > 450 ms, female > 470 ms); 9) Any uncontrollable serious clinical research related problems (such as substance abuse, uncontrolled psychosis, uncontrollable pleural effusion and/or pericardial effusion, uncontrolled complications, including active infection, arterial Thrombosis and symptomati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Control Rate, DCR;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time-To-Progression, TTP;Objective Response Rate, ORR;Remission rate;Quality of Life; | — |
Countries
China
Contacts
Public ContactChunshan Li
The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine
Outcome results
None listed