Irinotecan Liposomes Combined with Epirubicin in Recurren... | NCT06766266

NCT06766266

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: TURBT unresectable	Experimental	If the recurrent tumor can't be excised by TURBT, participants will be assigned to this arm. Participants in this arm will complete the neoadjuvant therapy with irinotecan liposome (intravenous injection, once every two weeks for 1 month, dose increasing regimen: 37.6 mg/m2 and 56.5mg/m2) and epirubicin (intravesical instillation, once a week for 1 month, 50 mg), and the therapeutic effect was evaluated by pelvic enhanced MRI and cystoscopy. Judged by two urologists with senior professional title, patients with complete response and partial response were treated with TURBT and intravesical therapy. Patients with stable disease or progressive disease received subsequent therapy at the investigator's discretion. Participants will visit the clinic once every 2 weeks for checkups and tests.	Drug: Irinotecan liposome II combination therapy regimen
Arm B: TURBT resectable	Experimental	If the recurrent tumor can be excised by TURBT, participants will be assigned to this arm (Arm B). Participants in this arm will complete TURBT with immediate intravesical instillation of epirubicin (50 mg) within 24 hours after surgery. During the induction phase (the first 1 month after surgery), participants will receive the combined therapy with irinotecan liposome (intravenous injection, once every two weeks for 1 month, dose increasing regimen: 37.6 mg/m2 and 56.5mg/m2) and epirubicin (intravesical instillation, once a week for 1 month, 50 mg). In the next 6 months, participants will continue the intravesical instillation treatment with epirubicin (once a month, 50 mg). Participants will visit the clinic once every 2 weeks for checkups and tests in the first month, and once every 3 months after the first month.	Drug: Irinotecan liposome II combination therapy regimen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Irinotecan liposome II combination therapy regimen	Drug	In the A arm, the combined treatment with irinotecan liposome (intravenous injection, once every two weeks for 1 month, dose increasing regimen: 37.6 mg/m2 and 56.5mg/m2) and epirubicin (intravesical instillation, once a week for 1 month, 50 mg) is in the neoadjuvant therapy phase before TURBT surgery.

Outcomes Module

Measure	Description	Time Frame
Bone marrow suppression (Grade four)	Absolute Neutrophil Count < 0.510^9/L Platelet <2510^9/L leukocyte <1.0*10^9/L	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Safety and adverse events	The description of adverse events will be coded according to MedDRA terminology and graded according to NCI-CTCAE v5.0.	2 months
Objective remission rate (Arm A available)

Eligibility Module

Name	Role	Phone	Extension	Email
Xin Gou, Professor	Contact	0086+13650518875		cymnk@163.com

Name	Affiliation	Role
Xin Gou, Professor	cymnk@163.com	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Chongqing Medica University	Recruiting	Chongqing		400010	China

IPD Sharing Statement Module

The proportion of patients with complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) after treatment was calculated according to the recognized response evaluation criteria (such as New response evaluation criteria in solid tumours: Revised RECIST guideline , version 1.1).

CR: All tumor target lesions disappeared and no new lesions appeared. PR: The sum of maximum diameter of tumor target lesions decreased by ≥30%; SD: The sum of the maximum diameter of tumor target lesions did not shrink to PR, or increase to PD; PD: The sum of the maximum diameters of tumor target lesions increases at least ≥20%, or new lesions appear.