Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05723991
Other study ID # [222] LSZ (S137) No
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 28, 2022
Est. completion date September 28, 2025

Study information

Verified date February 2023
Source Tongji Hospital
Contact Zhiquan hu, doctor
Phone 13971656164
Email huzhiquan2000@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A multicenter, open, single arm, phase II clinical trial was designed for myometrial invasive bladder cancer to evaluate the efficacy and safety of RC48-ADC combined with gemcitabine in preoperative neoadjuvant treatment of MIBC, and provide high-level clinical evidence for gemcitabine combined with ADC in the treatment of MIBC


Description:

Patients with myometrial invasive bladder cancer expressing HER2 and not suitable for cisplatin chemotherapy were treated with vedixizumab (RC48) 2.0mg/kg, once every two weeks, intravenous drip (60-90min); Gemcitabine is 1000mg/m2, once every two weeks. After completing 3 cycles of neoadjuvant combined therapy, imaging evaluation was performed. If the tumor is T0, radical surgery for bladder cancer was performed; Otherwise, perform radical surgery for bladder cancer (total cystectomy+standard/extended lymph node dissection) after completing 1-3 cycles of treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date September 28, 2025
Est. primary completion date September 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Subjects voluntarily joined the study, signed the informed consent form, and were able to follow the study and follow-up procedures 2. Age 18-75 3. Suitable and planned for radical cystectomy (including lymph node dissection) 4. Clinical stage T2-T4aN0M0 (CT/MR/PET-CT evaluation) 5. Pathologically, it is urothelial carcinoma, and the patient has HER2 expression and refuses neoadjuvant chemotherapy or physical condition/renal function [glomerular filtration rate (GFR) 30-60mL/min], which is not suitable for neoadjuvant chemotherapy (pathology allows urothelial carcinoma to merge with other variant subtypes, with urothelial carcinoma as the main type) 6. ECOG score 0 or 1 7. There is residual tumor after TURBT (cystoscopy or imaging evidence) 8. The blood test of subjects should meet the following requirements Exclusion Criteria: 1. Receive live attenuated vaccine within 4 weeks before enrollment or during the study period. 2. Have received systemic chemotherapy and targeted therapy of anti-PD-1, PD-L1 and HER2 in the past 6 months 3. Known allergy to gemcitabine/RC48 and its components 4. Active, known or suspected autoimmune diseases. 5. A history of primary immunodeficiency is known.

Study Design


Intervention

Drug:
Disitamab Vedotin and Gemcitabine
Disitamab Vedotin (RC48) 2.0mg/kg, once every two weeks, intravenous drip (60-90 min); Gemcitabine is 1000mg/m2, once every two weeks. After completing 3 cycles of neoadjuvant combined therapy, imaging evaluation was performed. If the tumor is T0, radical surgery for bladder cancer was performed; Otherwise, perform radical surgery for bladder cancer after completing 1-3 cycles of treatment (total cystectomy+standard/extended lymph node dissection)

Locations

Country Name City State
China Tongji Hospital Wuhan Hubei
China Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Chunguang yang (101937)

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pathologic Complete Response Neoadjuvant therapy and postoperative pathology confirmed that the primary tumor was in complete remission (stage ypT0) and had no residual tumor cells, regardless of whether the regional lymph nodes were involved or not. three years
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Completed NCT03520231 - Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases Phase 2
Recruiting NCT05775874 - A Study to Evaluate the Safety and Efficacy of AZD4547 Combination With Tislelizumab in Patients With mUC Phase 2
Recruiting NCT04623502 - An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy N/A
Recruiting NCT04617756 - Safety & Efficacy of Durvalumab+Neoadjuvant Chemotherapy for High-risk Urothelial Carcinoma of the Upper Urinary Tract Phase 2
Recruiting NCT06116396 - Liquid Biospy for Urinary Cancers
Active, not recruiting NCT03039413 - Copper Cu-64 TP3805 PET/CT in Imaging Patients With Urothelial Cancer Undergoing Surgery or Biopsy Early Phase 1
Completed NCT02795156 - Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations Phase 2
Terminated NCT03915405 - KHK2455 (IDO Inhibitor) Plus Avelumab in Adult Subjects With Advanced Bladder Cancer Phase 1
Completed NCT03980041 - Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275) Phase 2
Completed NCT04452214 - A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors Phase 1
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Recruiting NCT05911295 - Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2 Phase 3
Terminated NCT01093066 - Prospective Multicentric Evaluation of a Bladder Preservation Strategy Phase 2
Terminated NCT01042795 - Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy Phase 2
Recruiting NCT06022757 - Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19) Phase 1/Phase 2
Recruiting NCT03212404 - Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers Phase 1
Recruiting NCT04140526 - Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC Phase 1/Phase 2
Completed NCT04077359 - Prospective Trial for Examining Hematuria Using Computed Tomography N/A