NCT07665697

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
35mo left

Started Jun 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jun 2026Jun 2029

First Submitted

Initial submission to the registry

June 19, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

June 30, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2029

Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

June 19, 2026

Last Update Submit

June 19, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • overall survival

    2 year

  • progression-free time

    2 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, 610041, China

Location

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Xue Jianxin, MD. Phd

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. PhD

Study Record Dates

First Submitted

June 19, 2026

First Posted

June 24, 2026

Study Start

June 30, 2026

Primary Completion (Estimated)

June 15, 2029

Study Completion (Estimated)

June 15, 2029

Last Updated

June 24, 2026

Record last verified: 2026-06

Locations