Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin | Experimental | ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin | Drug | RC48-ADC combined with hypofractionated radiotherapy, PD-L1 inhibitor sequential GM- CSF and Thymopentin |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate #ORR# | Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR). | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 36 months |
| Disease control rate (DCR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liyuan Zhang, doctor | Contact | 0512-67784829 | zhangliyuan126@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Soochow University | Suzhou | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41308040 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
DCR was defined as the percentage of participants with a complete response (CR), partial response (PR), or stable disease (SD). |
| 36 months |
| Overall survival (OS) | OS was defined as the time from the first administration of study treatment to death from any cause. | 36 months |
| Adverse event | rate of adverse events | 36 months |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D016305 | Thymopentin |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013946 | Thymopoietins |
| D013951 | Thymus Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided