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

UNKNOWNPHASE2

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

A Prospective Multicenter Clinical Study of Hypofractionated Radiotherapy Combined With PD-1 Inhibitor Sequential GM-CSF and IL-2 for the Treatment of Advanced Refractory Solid Tumors

NCT04892498•Second Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

Summary

This is a prospective multicenter clinical study to determine the efficacy and safety of hypofractionated radiotherapy combined with PD-1 inhibitor sequential GM-CSF and IL-2 for advanced multiple metastatic solid tumors

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years.
•2. The enrolled patients meet the recurrence or metastasis of advanced solid malignant tumors, have a clear pathological diagnosis report or medical history, the guidelines do not clearly recommend standard treatment plans or cannot tolerate standard treatment plans, and have clear measurable metastatic lesions (\>1cm);
•3. No congestive heart failure, unstable angina, or unstable arrhythmia occurred in the past 6 months.
•4. The patient's activity status score is 0-3 points based on the Eastern Cooperative Oncology Group (ECOG) scoring method, and the life expectancy assessment is ≥3 months.
•5. No serious hematopoietic function, abnormal heart, lung, liver, kidney function and immune deficiency in the past.
•6. One week before admission, the absolute value of T lymphocytes was ≥0.5 times the lower limit of normal, and neutrophils ≥1.0×109/L; AST and ALT were ≤3.0 times the upper limit of normal (for liver cancer/liver metastasis ≤5.0 times) Upper limit of normal); creatinine ≤3.0 times the upper limit of normal.
•7. The patient have the ability to understand and voluntarily sign an informed consent form.

Exclusion Criteria

•1. Pregnant or breastfeeding women.
•2. Those with a history of other malignant diseases in the last 5 years, except for cured skin cancer and cervical carcinoma in situ.
•3. If there is a history of uncontrolled epilepsy, central nervous system disease or mental disorder, the investigator's judgment of its clinical severity may hinder the signing of informed consent or affect the patient's compliance with medication.
•4. Clinically serious (ie active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) grade II or more severe congestive heart failure, or severe arrhythmia requiring drug intervention, or recent A history of myocardial infarction within 12 months.
•5. Those who need immunosuppressive therapy for organ transplantation.
•6. A known major active infection, or the researcher's judgment has major blood, kidney, metabolism, gastrointestinal, endocrine function or metabolic disorders, or other serious uncontrolled accompanying diseases.
•7. Those who are allergic to any research drug ingredients.
•8. A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation, or those with other immune-related diseases that require long-term oral hormone therapy.
•9. In the period of acute and chronic tuberculosis infection (T-spot test is positive, patients with suspected tuberculosis foci on chest X-ray).
•10. Other situations that the researcher thinks are not suitable for inclusion in the group.

Locations (16)

Peking University Third Hospital

Beijing, China

Hunan Cancer Hospital

Changsha, China

The Second Xiangya Hospital of Central South University

Changsha, China

Xiangya Hospital of Central South University

Changsha, China

Chongqing University Cancer Hospital

Chongqing, China

The Sixth Affiliated Hospital ，Sun Yat-seen University

Guangzhou, China

Cancer Hospital of The University of Chinese Academy of Sciences

Hangzhou, China

The First Affiliated Hospital of USTC

Hefei, China

Shandong Provincial Tumor Hospital

Jinan, China

The Second Affiliated Hospital of Nanchang University

Nanchang, China

Key Dates

Start Date

May 30, 2021

Primary Completion Date

August 1, 2023

Completion Date

August 1, 2024

Last Updated

August 9, 2022

Enrollment

ESTIMATED participants

Conditions

Advanced Refractory Solid Tumors

Interventions

Hypofractionated radiotherapy

RADIATION

PD-1 inhibitor

DRUG

GM-CSF

DRUG

IL-2

DRUG

Contacts

Liyuan Zhang, Dr

CONTACT

0086-0512-67784827 zhangliyuan126@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 9, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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