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

NCT04892498 | Unknown Phase 2

• 1 other identifier: JD-LK-2021-035-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 16

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

Conditions

Advanced Refractory Solid Tumors

Keywords

hypofractionated radiotherapy; PD-1 inhibitor; GM-CSF; IL-2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall response rate，ORR

  Up to 3 years

• Disease control rate，DCR

  Up to 3 years

• Overall survival，OS

  Up to 3 years

Study Arms (1)

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

EXPERIMENTAL

Radiation: Hypofractionated radiotherapy; Drug: PD-1 inhibitor; Drug: GM-CSF; Drug: IL-2

Interventions

Hypofractionated radiotherapy RADIATION

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

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

PD-1 inhibitor DRUG

q3w, until PD

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

GM-CSF DRUG

200μg, D1-D7, ≥8 cycles

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

IL-2 DRUG

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• 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);
• No congestive heart failure, unstable angina, or unstable arrhythmia occurred in the past 6 months.
• 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.
• No serious hematopoietic function, abnormal heart, lung, liver, kidney function and immune deficiency in the past.
• 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.
• The patient have the ability to understand and voluntarily sign an informed consent form.

You may not qualify if:

• Pregnant or breastfeeding women.
• Those with a history of other malignant diseases in the last 5 years, except for cured skin cancer and cervical carcinoma in situ.
• 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.
• 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.
• Those who need immunosuppressive therapy for organ transplantation.
• 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.
• Those who are allergic to any research drug ingredients.
• 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.
• In the period of acute and chronic tuberculosis infection (T-spot test is positive, patients with suspected tuberculosis foci on chest X-ray).

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead

Study Sites (16)

Peking University Third Hospital

Beijing, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, China

NOT YET RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, China

NOT YET RECRUITING

Xiangya Hospital of Central South University

Changsha, China

NOT YET RECRUITING

Chongqing University Cancer Hospital

Chongqing, China

NOT YET RECRUITING

The Sixth Affiliated Hospital ，Sun Yat-seen University

Guangzhou, China

NOT YET RECRUITING

Cancer Hospital of The University of Chinese Academy of Sciences

Hangzhou, China

RECRUITING

The First Affiliated Hospital of USTC

Hefei, China

RECRUITING

Shandong Provincial Tumor Hospital

Jinan, China

NOT YET RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, China

NOT YET RECRUITING

Jiangsu Cancer Hospital

Nanjing, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, China

NOT YET RECRUITING

Second Affiliated Hospital of Soochow University

Suzhou, China

RECRUITING

Renmin Hospital of Wuhan University

Wuhan, China

NOT YET RECRUITING

Jiangyin People's Hospital

Wuxi, China

RECRUITING

The Affilated Hospital of Xuzhou Medical University

Xuzhou, China

RECRUITING

MeSH Terms

Interventions

Radiation Dose Hypofractionation; Immune Checkpoint Inhibitors; Granulocyte-Macrophage Colony-Stimulating Factor; Interleukin-2

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Interleukins; Lymphokines

Study Officials

• Liyuan Zhang, Dr

  Second Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liyuan Zhang, Dr

CONTACT

0086-0512-67784827; zhangliyuan126@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: May 19, 2021
• Study Start: May 30, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2024
• Last Updated: August 9, 2022

Record last verified: 2021-08

Locations

CN (16)