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

What Was Tested

In this phase 2 trial, researchers set out to test Thymopentin.

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.

It had 1 arm (groups): ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin (experimental).

ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 29 planned participants were the target.

It was open to people of any sex aged from 75 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Aged 75 years and above. 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.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: current pregnancy or lactation; uncontrolled epilepsy, central nervous system diseases or mental illness; received allogeneic hematopoietic stem cell transplantation or solid organ transplantation.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Thymopentin study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2023-10-25 with completion listed for 2026-10-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Objective Response Rate #ORR# (time frame: 36 months).

It also tracked 4 secondary outcomes, for example Progression-free Survival (PFS), Disease control rate (DCR), Overall survival (OS) and Adverse event.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Thymopentin in 29 people.

Its size is small, so on its own it can only give an early look.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Thymopentin compound page, all human trials.