Overview

Thymalfasin-based PRaG Mode for Advanced Refractory Solid Tumors

Status:
Recruiting

Trial end date:
2025-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Second Affiliated Hospital of Soochow University

Collaborator:

SciClone Pharmaceuticals

Treatments:

Immune Checkpoint Inhibitors
Thymalfasin

Criteria

Inclusion Criteria:

1. Subjects aged≥ 18 years;

2. Enrolled subjects who shall meet the criteria of recurrent or metastatic advanced
solid malignant tumors, have a definite pathology diagnosis report or medical history,
without definitely recommended standard treatment regimen in the guidelines, and
cannot tolerate or are unwilling to receive the standard treatment regimen, and have
clear, measurable metastatic lesions (>1cm);

3. Subjects who have not suffered from congestive heart failure, unstable angina, or
unstable arrhythmia in the past 6 months;

4. Subjects who have the ECOG (Eastern Cooperative Oncology Group) performance status
score of 0-3 and the life expectancy≥3 months;

5. Subjects who have no serious abnormalities of hematopoietic functions, heart, lung,
liver, kidney functions, or immune deficiency in the past;

6. Subjects whose AST and ALT levels are ≤3.0 times the upper limit of normal (≤5.0 times
the upper limit of normal for patients with liver cancer/metastasis liver carcinoma),
and creatinine level is ≤3.0 times the upper limit of normal one week before
enrollment.

7. Subjects who shall have the ability to understand and voluntarily sign the informed
consent forms.

Exclusion Criteria:

1. Pregnant or lactating women.

2. Subjects who have a history of other malignant diseases in the last 5 years, expect
for：malignancies that can be cured after treatment (including but not limited to
adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell
skin cancer).

3. Subjects who have a history of uncontrolled epilepsy, CNS disease or mental disorder.

4. Subjects with clinically severe (active) cardiac disease such as symptomatic coronary
heart disease, NYHA Class II or worse congestive heart failure, or severe arrhythmias
requiring medical intervention, or a history of myocardial infarction within the last
12 months.

5. Subjects who require immunosuppressive therapy for organ transplantation.

6. Subjects with known significant active infection or significant disorders of blood,
kidney, metabolism, gastrointestinal, endocrine functions or metabolisms as judged by
the Investigator, or other severe, uncontrolled concomitant diseases.

7. Subjects who are allergic to any ingredient of the investigational drug.

8. Subjects who have a medical history of immunodeficiency, including HIV-positive or
other acquired or congenital immunodeficiency diseases, or those with a history of
organ transplantation, or those with other immune-related diseases requiring long-term
oral hormone therapy.

9. Subjects who are in the stage of acute and chronic tuberculosis infections (positive
result of T-spot test, with suspected tuberculous lesions on chest X-ray).

10. Other conditions that are not suitable for enrollment in the Investigator's opinions.