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

June 19, 2026 updated by: You Lu, Sichuan University
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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Chengdu, China, 610041
        • West China Hospital of Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Age ≥ 18 years;
  2. Histologically or cytologically confirmed malignant tumor;
  3. 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.);
  4. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);
  5. Adequate organ function (with reference to laboratory tests such as complete blood count, liver and kidney function tests);
  6. Voluntary participation in this study, signed informed consent, and willingness to comply with follow-up.

Exclusion Criteria:

  1. Active autoimmune disease requiring systemic immunosuppressive therapy (physiological doses of glucocorticoid replacement therapy or inhaled steroids are permitted);
  2. Active, uncontrolled severe infection, or known human immunodeficiency virus (HIV) infection;
  3. Pregnant or breastfeeding women;
  4. Any unstable systemic disease (including but not limited to severe cardiac, hepatic, or renal insufficiency).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 2 year
2 year
progression-free time
Time Frame: 2 year
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

June 15, 2029

Study Completion (Estimated)

June 15, 2029

Study Registration Dates

First Submitted

June 19, 2026

First Submitted That Met QC Criteria

June 19, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • （2026）356

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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