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

Advanced Refractory Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04892498
• Other study ID #: JD-LK-2021-035-01
• Status: Recruiting
• Phase: Phase 2
• Start date: May 30, 2021
• Est. completion date: August 2024

Study information

• Verified date: August 2021
• Source: Second Affiliated Hospital of Soochow University
• Contact: Liyuan Zhang, Dr
• Phone: 0086-0512-67784827
• Email: zhangliyuan126[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: August 2024
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Refractory Solid Tumors
• Neoplasms

Intervention

Radiation:
• Hypofractionated radiotherapy
10-24Gy/5-8Gy/2-3f

Drug:
• PD-1 inhibitor
q3w, until PD
• GM-CSF
200µg, D1-D7, =8 cycles
• IL-2
at a dose of 2 million IU, D8-D14, =8 cycles

Locations

Country	Name	City	State
China	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	Jiangsu Cancer Hospital	Nanjing
China	Fudan University Shanghai Cancer Center	Shanghai
China	Second Affiliated Hospital of Soochow University	Suzhou
China	Renmin Hospital of Wuhan University	Wuhan
China	Jiangyin People's Hospital	Wuxi
China	The Affilated Hospital of Xuzhou Medical University	Xuzhou

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival,PFS	Time from cycle 1, day 1 of treatment to disease progression or death due to any cause	Up to 3 years
Secondary	Overall response rate,ORR	The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1.	Up to 3 years
Secondary	Disease control rate,DCR	The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) or stable disease (SD) using RECIST v1.1.	Up to 3 years
Secondary	Overall survival,OS	Time from cycle 1, day 1 of treatment until death due to any cause	Up to 3 years