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Safety and efficacy evaluation of immune checkpoint inhibitors in HIV-infected patients with advanced tumors: a real-world retrospective cohort study in China.

Safety and efficacy evaluation of immune checkpoint inhibitors in HIV-infected patients with advanced tumors: a real-world retrospective cohort study in China

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400081181
Enrollment
Unknown
Registered
2024-02-26
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV complicated with tumor

Interventions

queue A:None

Sponsors

Shanghai Public Health Clinical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Participants who visited Shanghai Public Health Clinical Center and other hospitals from January 1, 2015 to June 17, 2023 were included: Queue a 1) It conforms to the diagnostic criteria of AIDS in AIDS phase in China Guidelines for AIDS Diagnosis and Treatment (2021 Edition), and the subjects must agree to receive antiretroviral treatment when they are included in the study; 2) Age above 18 (inclusive); 3) All patients must be pathologically diagnosed with advanced tumors (locally advanced or metastatic) before entering the group, including but not limited to: lung cancer, head and neck cancer, cervical cancer, melanoma, anal cancer, pancreatic cancer, gastroesophageal cancer, triple negative breast cancer, bladder cancer, cholangiocarcinoma, Kaposi's sarcoma, lymphoma, ovarian cancer, Merkel cell cancer and any other tumor types whose immune checkpoint inhibitors have shown anti-tumor activity. 4) Agree to receive ICIs-based treatment when joining the group. Queue b Patients with HIV complicated with non-cell lung cancer in stage IV in cohort A were selected. According to this group of patients, the following variables were matched according to 1: 2: (1) age, (2) gender, (3)ICIs category, (4) use of concurrent chemotherapy (yes/no) and (5) times of systematic treatment before ICIS started, cohort B was selected.

Exclusion criteria

Exclusion criteria: 1) Participating in other interventional clinical studies; 2) Other untreated coexisting HIV-related malignant tumors;

Design outcomes

Primary

MeasureTime frame
Objective remission rate (ORR) of tumor;Progression-free survival (PFS);Overall survival (OS);

Secondary

MeasureTime frame
HIV RNA viral load;Lymphocyte count;

Countries

China

Contacts

Public ContactChen Jun

Shanghai Public Health Clinical Center

qtchenjun@163.com+86 180 1750 0639

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026