HIV infection
Conditions
Interventions
Control group:Platinum Based Chemotherapy + Immune Checkpoint Inhibitor + Pemetrexed
Experimental group:Bevacizumab + Immune Checkpoint Inhibitor + Pemetrexed
Sponsors
Southern Medical University Southern Hospital
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Voluntarily sign the written informed consent form, agree to comply with the study and complete follow-up visits; 2.Age >= 50 years, confirmed HIV positive, any sex; 3.Treatment-naïve, histologically or cytologically confirmed stage IV non-squamous non-small cell lung cancer according to the AJCC 8th edition lung cancer TNM staging, with no driver gene mutations (EGFR, ALK, ROS1, KRAS, BRAF, HER2, MET, RET all negative); 4.No prior anti-tumor therapy; 5.At least one measurable lesion as a target lesion (according to RECIST v1.1); 6.Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1; 7.Estimated life expectancy >= 3 months. 8.Adequate organ function; 9.Female participants of childbearing potential must agree to practice true abstinence or use highly effective contraceptive measures, and refrain from oocyte donation. A negative urine or serum pregnancy test is required within 3 days prior to the first dose of study drug (Cycle 1, Day 1). If the urine pregnancy test is positive or inconclusive, a serum pregnancy test must be performed. 10.Male participants must agree to practice true abstinence or use acceptable contraceptive methods, and refrain from sperm donation. 11.Expected good compliance with the study;
Exclusion criteria
Exclusion criteria: 1.Presence of active, uncontrolled serious opportunistic infection; 2.Concurrent other malignancy (except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been cured for >=5 years); 3.Presence of central nervous system (CNS) metastases that are not effectively controlled; 4.Active autoimmune disease requiring systemic treatment, or history of severe immune-related adverse events (irAEs) following prior immune checkpoint inhibitor therapy; 5.Significant bleeding tendency or recent (within 3 months) history of major bleeding events (e.g., gastrointestinal bleeding, intracranial hemorrhage); 6.Uncontrolled hypertension (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg despite medical treatment); 7.Major surgery, severe infection requiring hospitalization, or presence of non-healing wound or ulcer within 4 weeks prior to the first dose of study drug; 8.History of interstitial lung disease (ILD) or current non-infectious pneumonitis requiring corticosteroid therapy; 9.Severe dysfunction of vital organs (e.g., heart, lung, liver, kidney) precluding tolerance to study treatment; 10.Psychiatric illness, history of drug abuse, or any other condition that may compromise compliance with the study protocol; 11.Childbearing potential individuals (male or female) who do not use effective contraceptive measures, or pregnant or breastfeeding women; 12.Known allergy or hypersensitivity to any component of the study drugs; 13.Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, or any other drugs acting on T-cell co-stimulatory or checkpoint pathways (e.g., OX40, CD137); 14.Currently participating in another interventional clinical trial, or receipt of any investigational therapy for cancer treatment within 4 weeks prior to the first dose, or receipt of any monoclonal antibody for cancer therapy within 3 months prior to the first dose; 15.Any other condition that, in the investigator’s judgment, makes the patient unsuitable for participation in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HIV-related markers (CD4 T cell count, CD8 T cell count, CD4/CD8 ratio, HIV viral load, HIV-DNA reservoir);Patient?reported outcomes (LCSS, EORTC QLQ?C30, PSQI, BDI, GAD?7);Survival status, subsequent anti?cancer therapy;Tumour imaging;Adverse events (AEs/SAEs); | — |
Secondary
| Measure | Time frame |
|---|---|
| Medical history;Concomitant medications (including WBC/platelet growth factors, etc.);12?lead electrocardiogram (ECG);Hematology (complete blood count: WBC, RBC, Hb, PLT, neutrophils, etc.);Serum biochemistry (liver/kidney function, electrolytes, glucose, lipids, LDH, etc.);ECOG performance status;Coagulation profile (PT, APTT, INR, fibrinogen);Viral serology (HBV, HCV, EBV, CMV);Serum pregnancy test (ß?hCG);Cardiac function (left ventricular ejection fraction, LVEF);Physical examination, vital signs; | — |
Countries
China
Contacts
Public ContactPeng Jie
Southern Medical University Southern Hospital
Outcome results
None listed