Analysis of Efficacy and Outcomes of Immunotherapy for Malignant Tumors: A Prospective Non-interventional Clinical Study

ConditionsNeoplasms Drug Therapy Immune Checkpoint Inhibitors (ICIs)

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorSichuan University

About this trial

The population receiving immunotherapy is heterogeneous. Multiple factors, including combination treatment modalities, influence the immune response, and survival outcomes also vary among individuals receiving immunotherapy. The aim of this study is to develop and validate a clinical prediction model that can predict survival outcomes of immunotherapy for malignant tumors, and to assess the calibration and discrimination of this model in a prospective independent cohort.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years;

Histologically or cytologically confirmed malignant tumor;

Planned to receive immune checkpoint inhibitor (e.g., PD-1/PD-L1 inhibitor)-based therapy (monotherapy or in combination with chemotherapy/targeted therapy/radiotherapy, etc.);

At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);

Disqualifiers

Active autoimmune disease requiring systemic immunosuppressive therapy (physiological doses of glucocorticoid replacement therapy or inhaled steroids are permitted);

Active, uncontrolled severe infection, or known human immunodeficiency virus (HIV) infection;

Pregnant or breastfeeding women;

Any unstable systemic disease (including but not limited to severe cardiac, hepatic, or renal insufficiency).

Trial population

Patients aged ≥18 years with histologically or cytologically confirmed malignant tumors and who are planned to receive immune checkpoint inhibitor-based therapy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

overall survival

Time frame

2 year

progression-free time

Time frame

2 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: