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Advanced Refractory Solid TumorsPhase 2NCT04892498

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 study testing Hypofractionated radiotherapy, PD-1 inhibitor and GM-CSF in people with Advanced Refractory Solid Tumors, run by Second Affiliated Hospital of Soochow University at 16 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Refractory Solid Tumors
What is being tested?
Hypofractionated radiotherapy, PD-1 inhibitor and GM-CSF
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
16 sitesChina
Study dates
30 May 2021to Aug 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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).
  • Other situations that the researcher thinks are not suitable for inclusion in the group.

Trial locations and contacts

16 sites in 1 country.

Liyuan Zhang, Dr contact

0086-0512-67784827

zhangliyuan126@126.com

16 sites in 1 country

China16 sites, 16 recruiting

  • Peking University Third Hospital

    Beijing

    Hao Wang, Dr

    Not yet recruiting

  • Hunan Cancer Hospital

    Changsha

    Pei Yang, Dr

    Not yet recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha

    Pin Liu, Dr

    Not yet recruiting

  • Xiangya Hospital of Central South University

    Changsha

    Haijun Wu, Dr

    Not yet recruiting

  • Chongqing University Cancer Hospital

    Chongqing

    Wei Zhou, Dr

    Not yet recruiting

  • The Sixth Affiliated Hospital ，Sun Yat-seen University

    Guangzhou

    Xiangbo Wan, Dr

    Not yet recruiting

  • Cancer Hospital of The University of Chinese Academy of Sciences

    Hangzhou

    Wei Feng, Dr

    Recruiting

  • The First Affiliated Hospital of USTC

    Hefei

    Dong Qian, Dr

    Recruiting

  • Shandong Provincial Tumor Hospital

    Jinan

    Dali Han, Dr

    Not yet recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang

    Hua Wang, Dr

    Not yet recruiting

  • Jiangsu Cancer Hospital

    Nanjing

    Li Yin, Dr

    Not yet recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai

    Guichao Li, Dr

    Not yet recruiting

  • Second Affiliated Hospital of Soochow University

    Suzhou

    Liyuan Zhang, Dr, 0086-0512-67784827, zhangliyuan126@126.com

    Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan

    Xiangpan Li, Dr

    Not yet recruiting

  • Jiangyin People's Hospital

    Wuxi

    Jiang Wang, Dr

    Recruiting

  • The Affilated Hospital of Xuzhou Medical University

    Xuzhou

    Jiangshe Wang, Dr

    Recruiting

Other trials in China

About this study

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

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

Being tested
Hypofractionated radiotherapy, PD-1 inhibitor, GM-CSF, IL-2
Keywords
hypofractionated radiotherapy, PD-1 inhibitor, GM-CSF, IL-2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypofractionated radiotherapyRadiation

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

  • PD-1 inhibitorDrug

    q3w, until PD

  • GM-CSFDrug

    200μg, D1-D7, ≥8 cycles

  • IL-2Drug

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

Study groups in NCT04892498
Study groupRoleWhat they receive
RT+PD-1+GM-CSF+IL-2ExperimentalNot described
Receives: Radiation: Hypofractionated radiotherapy; Drug: PD-1 inhibitor; Drug: GM-CSF; Drug: IL-2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression free survival，PFS

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

    Measured: Up to 3 years

Secondary outcomes (3)

  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.

    Measured: 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.

    Measured: Up to 3 years

  3. Overall survival，OS

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

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2021
  2. Study start30 May 2021
  3. Primary completionAug 2023 (estimated)
  4. Study completionAug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04892498
Sponsor's protocol ID
JD-LK-2021-035-01
Status last verified
Aug 2021
First submitted
19 Apr 2021
Last updated
9 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hypofractionated radiotherapy, PD-1 inhibitor and GM-CSF in people with Advanced Refractory Solid Tumors, run by Second Affiliated Hospital of Soochow University at 16 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Liyuan Zhang, Dr (0086-0512-67784827, zhangliyuan126@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression free survival，PFS (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04892498.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.

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