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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04892498
Other study ID # JD-LK-2021-035-01
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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