Clinical Trials Logo
  1. Home
  2. Urinary Bladder Neoplasm
  3. NCT03389438

Autologous Cellular Immunotherapy in Patients With Metastatic Bladder Urothelial Carcinoma

Urinary Bladder Neoplasm Clinical Trial

Official title:
A Single-center Randomized Controlled Trial of Autologous Cellular Immunotherapy in Patients With Metastatic Bladder Urothelial Carcinoma Treated With First-line Gemcitabine Plus Cisplatin

Clinical Trial Summary

Autologous cellular immunotherapy is to collect patient's own immune cells and infuse back into the patient's body after culture in vitro that can activate the anti-tumor immune response and achieve the purpose of cancer treatment. Central memory T (Tcm) cells are effective anti-tumor immune cells with long-term in vivo survival and self-renewal capacity. Combination of autologous Tcm cells immunotherapy with other therapies, such as surgery and chemotherapy, can effectively prolong the patient's life, prevent the recurrence and metastasis of cancers, and improve the quality of life of patients. This study will recruit patients with pathologically and radiographically confirmed metastatic bladder urothelial carcinoma that the efficacy is evaluated as partial response (PR) or complete response (CR) after 4 cycles of the standard first-line gemcitabine plus cisplatin chemotherapy. Patients must have adequate hematologic and end-organ function, performance status and no contraindications to receive autologous Tcm cells immunotherapy. All participants will be treated with standard first-line gemcitabine plus cisplatin chemotherapy before enrolment. This clinical trial was designed with a single-center randomized controlled trial. The study will recruit 56 patients that will be divided into treatment group and control group as 1:1 according to the randomization. Patients of treatment group will be treated with twice autologous Tcm cells immunotherapy after chemotherapy. These patients will be infused in 2-4×10^9 cells/100 ml after chemotherapy for 1 month, then cells will be infused as the same dose after another month. All patients will be followed up with hospital visits and telephone interviews to second-line treatment for disease progression. The observation period of patients is 24 months. The objective of the study is to evaluate the clinical efficacy and safety of autologous Tcm cells immunotherapy in patients with metastatic bladder epithelial carcinoma treated with first-line gemcitabine plus cisplatin according to the progression-free survival (PFS) and overall survival (OS) of these patients.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03389438
Study type Interventional
Source Beijing Huanxing Cancer Hospital
Contact
Status Terminated
Phase Phase 2
Start date February 26, 2018
Completion date October 31, 2021
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05429710 - SOX2 & PDL1 Expression on Urinary Bladder Carcinoma
Not yet recruiting NCT05097105 - Role of Diffusion -Weighted MRI in Evaluation of Urinary Bladder Masses
Completed NCT02966535 - The Effect of Prolonged Inspiratory Time on Gas Exchange During Robot-assisted Laparoscopic Surgery With Steep Trendelenburg Position : A Crossover Randomized Clinical Trial N/A
Completed NCT02977143 - Positive End-expiratory Pressure-induced Increase in Central Venous Pressure as a Predictor of Fluid Responsiveness in Robot-assisted Laparoscopic Surgery N/A
Recruiting NCT04144270 - The Importance of Muscle Function in Patients With Disseminated Bladder Cancer
Completed NCT05946369 - Neutrophils to Lymphocytes Ratio in Predicting the Response to BCG in Non-muscle Invasive Bladder Cancer
Recruiting NCT05786716 - DETERMINE Trial Treatment Arm 04: Trastuzumab in Combination With Pertuzumab in Adult, Teenage/Young Adult and Paediatric Patients With Cancers With HER2 Amplification or Activating Mutations Phase 2/Phase 3
Recruiting NCT06238479 - A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors Phase 1
Completed NCT02311101 - Phase I Mitomycin Combined With Bacillus Calmette-Guérin (BCG) for Bladder Cancer Phase 1
Recruiting NCT04811846 - CTC Quantification During TURBT and PKVBT of Transitional Cell Carcinoma in Purging Fluid and Blood N/A
Not yet recruiting NCT06465069 - A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors Phase 1
Recruiting NCT04576286 - Holmium Versus Bipolar en Bloc Transurethral Resection of Urothelium Tumor of the Urinary Bladder Phase 3
Completed NCT02857634 - Confocal Microscopy Dual Band in the Management of Bladder Cancer
Recruiting NCT04561362 - Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies Phase 1/Phase 2
Recruiting NCT04442724 - Bladder Fiducial Markers and Multiparametric-MRI (Mp-MRI) to Optimize Bladder Chemo-radiotherapy N/A
Recruiting NCT04029948 - Laser vs. Electorsurgical Enbloc Resection of Bladder Tumours N/A
Terminated NCT02952989 - A Safety Study of SGN-2FF for Patients With Advanced Solid Tumors Phase 1
Recruiting NCT06237920 - Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab Phase 2
Completed NCT03785925 - A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer Phase 2
Completed NCT03636256 - Evaluation of NanoDoce® in Participants With Urothelial Carcinoma Phase 1/Phase 2