Clinical trial NCT04892498: Hypofractionated Radiotherapy Combined With PD-1 Inhibitor Sequential GM-CSF and IL-2 for the Treatment of Advanced Refractory Solid Tumors (PRaG2.0)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Refractory Solid Tumors
Keywords: hypofractionated radiotherapy
PD-1 inhibitor
GM-CSF
IL-2
Lead sponsor: Second Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: progression free survival，PFS
timeFrame: Up to 3 years
Secondary outcomes:
measure: Overall response rate，ORR
timeFrame: Up to 3 years
measure: Disease control rate，DCR
timeFrame: Up to 3 years
measure: Overall survival，OS
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital ，Sun Yat-seen University
city: Hangzhou
country: China
facility: Cancer Hospital of The University of Chinese Academy of Sciences
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC
city: Jinan
country: China
facility: Shandong Provincial Tumor Hospital
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Suzhou
country: China
facility: Second Affiliated Hospital of Soochow University
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Wuxi
country: China
facility: Jiangyin People's Hospital
city: Xuzhou
country: China
facility: The Affilated Hospital of Xuzhou Medical University
Study officials:
affiliation: Second Affiliated Hospital of Soochow University
name: Liyuan Zhang, Dr
role: PRINCIPAL_INVESTIGATOR
References: