CClinicalTrials.gg
Status unknownNCT04892498Updated Aug 9, 2022

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

A Phase 2 interventional study of Hypofractionated radiotherapy and PD-1 inhibitor in Advanced Refractory Solid Tumors, sponsored by Second Affiliated Hospital of Soochow University. Status unknown at 16 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-09.

Sponsored by Second Affiliated Hospital of Soochow University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
66
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Advanced Refractory Solid Tumors

Browse trials for

Keywords

  • hypofractionated radiotherapy
  • PD-1 inhibitor
  • GM-CSF
  • IL-2
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 66 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Second Affiliated Hospital of Soochow University is the lead sponsor of 60 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

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

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

Interventions

  • RadiationHypofractionated radiotherapy

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

  • DrugPD-1 inhibitor

    q3w, until PD

  • DrugGM-CSF

    200μg, D1-D7, ≥8 cycles

  • DrugIL-2

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

06

What researchers measure

Primary outcomes

  1. progression free survival,PFS

    Time from cycle 1, day 1 of treatment to disease progression or death due to any cause

    Time frame: Up to 3 years

Secondary outcomes

  1. 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.

    Time frame: Up to 3 years

  2. 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.

    Time frame: Up to 3 years

  3. Overall survival,OS

    Time from cycle 1, day 1 of treatment until death due to any cause

    Time frame: Up to 3 years

07

Study locations

5 of 16 sites recruiting
  • Peking University Third Hospital
    Beijing, China
    • Hao Wang, Dr · Contact
    Not yet recruiting
  • Hunan Cancer Hospital
    Changsha, China
    • Pei Yang, Dr · Contact
    Not yet recruiting
  • The Second Xiangya Hospital of Central South University
    Changsha, China
    • Pin Liu, Dr · Contact
    Not yet recruiting
  • Xiangya Hospital of Central South University
    Changsha, China
    • Haijun Wu, Dr · Contact
    Not yet recruiting
  • Chongqing University Cancer Hospital
    Chongqing, China
    • Wei Zhou, Dr · Contact
    Not yet recruiting
  • The Sixth Affiliated Hospital ,Sun Yat-seen University
    Guangzhou, China
    • Xiangbo Wan, Dr · Contact
    Not yet recruiting
  • Cancer Hospital of The University of Chinese Academy of Sciences
    Hangzhou, China
    • Wei Feng, Dr · Contact
    Recruiting
  • The First Affiliated Hospital of USTC
    Hefei, China
    • Dong Qian, Dr · Contact
    Recruiting
  • Shandong Provincial Tumor Hospital
    Jinan, China
    • Dali Han, Dr · Contact
    Not yet recruiting
  • The Second Affiliated Hospital of Nanchang University
    Nanchang, China
    • Hua Wang, Dr · Contact
    Not yet recruiting
  • Jiangsu Cancer Hospital
    Nanjing, China
    • Li Yin, Dr · Contact
    Not yet recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, China
    • Guichao Li, Dr · Contact
    Not yet recruiting
  • Second Affiliated Hospital of Soochow University
    Suzhou, China
    Recruiting
  • Renmin Hospital of Wuhan University
    Wuhan, China
    • Xiangpan Li, Dr · Contact
    Not yet recruiting
  • Jiangyin People's Hospital
    Wuxi, China
    • Jiang Wang, Dr · Contact
    Recruiting
  • The Affilated Hospital of Xuzhou Medical University
    Xuzhou, China
    • Jiangshe Wang, Dr · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04892498
Lead sponsor
Second Affiliated Hospital of Soochow University
Responsible party
Sponsor
First posted
May 19, 2021
Start date
May 30, 2021
Primary completion
Aug 2023 (estimated)
Completion
Aug 2024 (estimated)
Last update
Aug 9, 2022

Study contacts

Liyuan Zhang, Dr
Contact
zhangliyuan126@126.com
0086-0512-67784827
Liyuan Zhang, Dr
principal investigator · Second Affiliated Hospital of Soochow University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion