NeoplasmsNCT07665697
Analysis of Efficacy and Outcomes of Immunotherapy for Malignant Tumors: A Prospective Non-interventional Clinical Study
An observational study of Neoplasms and Drug Therapy, run by Sichuan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Drug Therapy, Immune Checkpoint Inhibitors (ICIs)
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to 15 Jun 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥18 years with histologically or cytologically confirmed malignant tumors and who are planned to receive immune checkpoint inhibitor-based therapy.
Who may be able to join
- 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);
- Adequate organ function (with reference to laboratory tests such as complete blood count, liver and kidney function tests);
- Voluntary participation in this study, signed informed consent, and willingness to comply with follow-up.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Neoplasms, Drug Therapy, Immune Checkpoint Inhibitors (ICIs)
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 2 year
progression-free time
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion15 Jun 2029 (estimated)
- Study completion15 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, You Lu, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665697
- Sponsor's protocol ID
- （2026）356
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No