lung cancer
Conditions
Interventions
Experiment group:Recombinant human adenovirus type 5 + neoadjuvant chemotherapy
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Tumor amenable to surgical resection; 2. Patients have not receive any previous systemic treatment for lung cancer, including surgery, chemotherapy, radiotherapy, targeted, hormone or immune therapy; 3. Diagnosed by histopathology and cytology as stage III (according to AJCC TNM staging, 7th edition) lung cancer, including adenocarcinoma and squamous cell carcinoma; 4. Aged 18 to 75 years, male or female; 5. Voluntarily sign the informed consent form and be able to participate the follow-up; 6. Have measurable diseases assessed by the investigator according to RECIST Version 1.1 and iRECIST; 7. ECOG performance status score 0-2; 8. Expected survival >= 3 months; 9. Laboratory tests must meet the following criteria: WBC >= 3.0 x 10^9/L, absolute neutrophil count >= 1.5 x 10^9/L, platelet count >= 100 x 10^9/L, hemoglobin >= 90 g/L; INR = 50ml/min; 10. Women of childbearing age during the study and within 3 months after the end of the treatment period agree to take effective contraceptive methods; serum or urine HCG test within 7 days before the enrollment of non-surgically sterilized female patients of childbearing age must be negative; male patients and male patients' partners must agree to use effective contraceptive measures during the study.
Exclusion criteria
Exclusion criteria: 1.Recurrent lung cancer; 2.Previous treatment with oncolytic virus (such as T-VEC); 3.Local lesions are not suitable for intratumoral injection; 4.Accompanied with malignant pleural effusion or ascites; 5.Have received antiviral therapy before the first dose of experimental treatment, such as aciclovir, ganciclovir, valaciclovir, etc.; 6.Known hypersensitivity to the study drug or its ingredients; 7.History of allergy to similar oncolytic virus biological agents; 8.HBsAg positive and clinical judgment of active hepatitis B; HCV antibody or treponema pallidum (TP) antibody or HIV antibody positive; 9.History of previous other malignant tumors (except cured or cancer-free survival more than 5 years of malignant tumors, such as skin basal cell carcinoma, cervical carcinoma in situ or papillary thyroid carcinoma); 10.Active autoimmune diseases or a history of autoimmune diseases that may recur; 11.Use of corticosteroids (daily dose of prednisone or equivalent > 10 mg) or other immunosuppressive drugs for systemic treatment within 14 days before enrollment; 12.Accompanied by any unstable systemic disease, including but not limited to: severe infection, uncontrolled diabetes, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardial infarction, congestive heart failure, severe arrhythmia requiring drug treatment, liver, kidney or metabolic disease; 13.Have received any other experimental drug treatment or participated in another interventional clinical trial within 14 days before receiving this study treatment; 14.Psychotropic drug abuse, alcoholism or drug abuse; 15.Pregnant or lactating women; 16.According to the investigator's judgment, the patient has other factors that may lead to the withdraw such as other serious diseases or serious laboratory abnormalities or accompanied by other factors that will affect the safety of subjects; 17.Any mental condition that hinders understanding or providing informed consent; 18.Those judged by investigator has other conditions that are not suitable for participating in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major pathological response (MPR); | — |
Secondary
| Measure | Time frame |
|---|---|
| pathological complete response, pCR;progression-free survival, PFS;overall response rate, ORR;Disease Control Rate, DCR;Overall Survival, OS;Safety;Tumor markers; | — |
Countries
China
Contacts
Public ContactZhu Yuming
Shanghai Pulmonary Hospital
Outcome results
None listed