Thymalfasin treatment combined with radiotherapy for advanced solid tumors

Treatment of Advanced Refractory Solid Tumors Based on Precise Thymalfasin-regulated PRaG Mode: an Open-label, Prospective, Multicenter Study (PRaG 5.0 Study)

This study is testing a new treatment that combines thymalfasin with radiation and other therapies to see if it can help people with advanced solid tumors that haven't responded to other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital of Soochow University (Academic / other)
• Locations: 1 site (Suzhou)
• Trial ID: NCT05790447 on ClinicalTrials.gov

What this trial studies

This Phase II trial investigates a novel treatment approach for patients with advanced refractory solid tumors using thymalfasin, a peptide that stimulates T lymphocyte activation, in combination with hypofractionated radiotherapy and sequential administration of a PD-1/PD-L1 inhibitor and GM-CSF. The treatment involves an activation cycle where thymalfasin is administered based on T lymphocyte counts, followed by targeted radiotherapy to metastatic lesions and subsequent immunotherapy. Patients will undergo at least two activation cycles, with maintenance therapy continuing the regimen of thymalfasin, GM-CSF, and PD-1/PD-L1 inhibitors. The goal is to evaluate the efficacy and safety of this combined approach in a challenging patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with recurrent or metastatic advanced solid tumors who have no standard treatment options available.

Not a fit: Patients with stable heart conditions or those who have serious abnormalities in organ functions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are resistant to standard therapies.

How similar studies have performed: While this approach combines established therapies, the specific combination and methodology are novel and have not been extensively tested in prior studies.

Eligibility 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.

Where this trial is running

Suzhou

• The Second Affiliated Hospital of SchoowUniversity — Suzhou, China (Recruiting)

Study contacts

• Study coordinator: Liyuan Zhang

Conditions Advanced Solid Tumor; Refractory Tumor