AzTrials
AzTrials

CarcinomaPhase 2NCT06112041

The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors (PRaG9.0)

A Phase 2 study testing ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin in people with Carcinoma and Solid Tumor, run by Second Affiliated Hospital of Soochow University at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

This is an open-label, single-arm, Phase II investigator-initiated trial of hypofractionated radiotherapy combined with PD-L1 inhibitor sequential GM-CSF and thymopentin for treatment of elderly patients with advanced solid tumors, when the HER-2 positive patients are treated with extra antibody-drug conjugate. Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Carcinoma, Solid Tumor
What is being tested?
ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteChina
Study dates
25 Oct 2023to 30 Oct 2026
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 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Aged 75 years and above
  • Standard treatment is ineffective (disease progresses after treatment) or locally advanced or metastatic malignant solid tumor patients who cannot tolerate standard therapy, cannot receive or do not have standard therapy
  • ECOG(Eastern Cooperative Oncology Group) performance is 0-3
  • Life expectancy greater than 3 months
  • serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤3.0*ULN, or AST and ALT≤5*ULN with hepatic metastasis; Total serum creatinine ≤1.5*ULN
  • Signed informed consent form

Who cannot join

  • Current pregnancy or lactation
  • History of other malignant tumors within 5 years prior to dose administration, expect for#malignancies that can be cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer)
  • Uncontrolled epilepsy, central nervous system diseases or mental illness
  • arrhythmia, congestive heart failure, or greater than or equal to Class 2 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction unstable angina, or acute coronary syndrome within 6 months prior to enrollment in the study
  • Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation
  • Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, uncontrolled diabetes
Show all 10Show fewer
  • Allergic to any of the ingredients used in the study
  • A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation, or other immune-related disease requiring long-term oral hormone therapy
  • Acute and chronic tuberculosis infection
  • Other disorders with clinical significance according to the researcher's judgment

Trial locations and contacts

1 site in 1 country.

Liyuan Zhang, doctor contact

0512-67784829

zhangliyuan126@126.com

China1 site

  • Second Affiliated Hospital of Soochow University

    Suzhou

    Liyuan Zhang, doctor, 0512-67784829, zhangliyuan126@126.com

Other trials in China

About this study

Official title: The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors(PRaG9.0)

This is an open-label, single-arm, Phase II investigator-initiated trial of hypofractionated radiotherapy combined with PD-L1 inhibitor sequential GM-CSF and thymopentin for treatment of elderly patients with advanced solid tumors, when the HER-2 positive patients are treated with extra antibody-drug conjugate.

Being tested
ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin
Medical subject headings
Carcinoma

What participants receive

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

  • ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and ThymopentinDrug

    RC48-ADC combined with hypofractionated radiotherapy, PD-L1 inhibitor sequential GM- CSF and Thymopentin

Study groups in NCT06112041
Study groupRoleWhat they receive
ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and ThymopentinExperimentalADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin
Receives: Drug: ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin

What is being measured

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

  1. Objective Response Rate #ORR#

    Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).

    Measured: 36 months

Secondary outcomes (4)

  1. Progression-free Survival (PFS)

    PFS was defined as the time from the first administration of study treatment to the first occurrence of disease progression as determined by investigator using RECIST v1.1 or death from any cause, whichever comes first.

    Measured: 36 months

  2. Disease control rate (DCR)

    DCR was defined as the percentage of participants with a complete response (CR), partial response (PR), or stable disease (SD).

    Measured: 36 months

  3. Overall survival (OS)

    OS was defined as the time from the first administration of study treatment to death from any cause.

    Measured: 36 months

  4. Adverse event

    rate of adverse events

    Measured: 36 months

Timeline

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

  1. First posted1 Nov 2023
  2. Study start25 Oct 2023 (estimated)
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Oct 2026 (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
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06112041
Sponsor's protocol ID
JD-LK2023082-I01
Status last verified
Oct 2023
First submitted
23 Oct 2023
Last updated
1 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhao X, Yang M, Zhang J, Kong Y, Xu M, Chen R, Yin Q, Wang S, Chen G, Xing P, Zhang L. Efficacy and Safety of PRaG Therapy in Elderly Patients with Advanced Malignant Tumors: A Prospective, Multicenter Clinical Study Protocol (PRaG 9.0 Study). Technol Cancer Res Treat. 2025 Jan-Dec;24:15330338251400412. doi: 10.1177/15330338251400412. Epub 2025 Nov 27.

    PubMed 41308040

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin in people with Carcinoma and Solid Tumor, run by Second Affiliated Hospital of Soochow University at 1 site 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 6 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 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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, doctor (0512-67784829, zhangliyuan126@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate #ORR# (time frame: 36 months). 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 NCT06112041, which also lists 1 linked publication.

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 1 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in