Thymalfasin-based PRaG Mode for Advanced Refractory Solid Tumors

NCT05790447 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-03-30

No results posted yet for this study

Summary

This is an open-label, single-arm, Phase II investigator-initiated trial of precise thymalfasin-regulated therapy combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF for treatment of advanced refractory solid tumors.

Conditions

  • Advanced Solid Tumor
  • Refractory Tumor

Interventions

DRUG

Thymalfasin

loading dose with thymalfasin based on the amounts of T lymphocyte

RADIATION

Radiotherapy

hypofractionated radiotherapy/SBRT

DRUG

PD-1/PD-L1 inhibitor

The PD-1/PD-L1 inhibitors are used within one week after radiotherapy

DRUG

GM-CSF

subcutaneous injection daily for 7 consecutive days

Sponsors & Collaborators

  • SciClone Pharmaceuticals

    collaborator INDUSTRY
  • Second Affiliated Hospital of Soochow University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2025-05-31
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05790447 on ClinicalTrials.gov