Thymalfasin-based PRaG Mode for Advanced Refractory Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors (PRaG9.0)

NCT06112041

Carcinoma Solid Tumor

NOT_YET_RECRUITING PHASE2

Hypofractionated Radiotherapy Combined With PD-1 Inhibitor Sequential GM-CSF and IL-2 for the Treatment of Advanced Refractory Solid Tumors (PRaG2.0)

NCT04892498

Advanced Refractory Solid Tumors

UNKNOWN PHASE2

PRaG Regimens Rechallenge for Patients With Resistance to PD1/PD-L1 Inhibitors in Refractory Advanced Solid Tumors.

NCT05530200

Metastatic Solid Tumor

UNKNOWN PHASE2

PraG With RANKL Inhibitor for the Treatment of Advanced Multiple Metastatic Solid Tumors

NCT05435768

Metastatic Solid Tumor

UNKNOWN

SBRT Combination With rhGM-CSF and Tα1 for Stage IV NSCLC Patients Who Failed in Second-line Chemotherapy

NCT02976740

Lung Cancer Metastatic

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

One cycle of activation cycle includes： Loading dose with thymalfasin was administrated based on the absolute number of T lymphocytes.

Radiotherapy (5 or 8Gy three fractions)was administrated to a metastatic lesion.

GM-CSF 200ug was subcutaneous injected for seven days from the first day of radiotherapy PD-1/L1 inhibitor was intravenous injected within one week after radiotherapy.

At least two activation cycles were administrated. Then maintenance treatment includes： Loading dose with thymalfasin was administrated based on the absolute number of T lymphocytes.

GM-CSF 200ug was subcutaneous injected for seven days. PD-1/L1 inhibitor was intravenous injected.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumor Refractory Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

A treatment cycle includes:

Loading dose with thymalfasin was administrated based on the absolute number of T lymphocytes.

Radiotherapy (5 or 8Gy three fractions)was administrated to a metastatic lesion GM-CSF 200ug was subcutaneous injected for seven days from the first day of radiotherapy PD-1/L1 inhibitor was intravenous injected within one week after radiotherapy

Group Type EXPERIMENTAL

Thymalfasin

Intervention Type DRUG

loading dose with thymalfasin based on the amounts of T lymphocyte

Radiotherapy

Intervention Type RADIATION

hypofractionated radiotherapy/SBRT

PD-1/PD-L1 inhibitor

Intervention Type DRUG

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

GM-CSF

Intervention Type DRUG

subcutaneous injection daily for 7 consecutive days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Thymalfasin

loading dose with thymalfasin based on the amounts of T lymphocyte

Intervention Type DRUG

Radiotherapy

hypofractionated radiotherapy/SBRT

Intervention Type RADIATION

PD-1/PD-L1 inhibitor

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

Intervention Type DRUG

GM-CSF

subcutaneous injection daily for 7 consecutive days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Thymosin alpha-1 PD-1/PD-L1 antibody :Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor for Injection

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No