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

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-30

Study Completion Date

2024-08-31

Brief Summary

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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

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Detailed Description

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Conditions

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Advanced Refractory Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RT+PD-1+GM-CSF+IL-2

Group Type EXPERIMENTAL

Hypofractionated radiotherapy

Intervention Type RADIATION

10-24Gy/5-8Gy/2-3f

PD-1 inhibitor

Intervention Type DRUG

q3w, until PD

GM-CSF

Intervention Type DRUG

200μg, D1-D7, ≥8 cycles

IL-2

Intervention Type DRUG

at a dose of 2 million IU, D8-D14, ≥8 cycles

Interventions

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Hypofractionated radiotherapy

10-24Gy/5-8Gy/2-3f

Intervention Type RADIATION

PD-1 inhibitor

q3w, until PD

Intervention Type DRUG

GM-CSF

200μg, D1-D7, ≥8 cycles

Intervention Type DRUG

IL-2

at a dose of 2 million IU, D8-D14, ≥8 cycles

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No