ICP-192 is a white, round, uncoated table

ICP-192

Jun Guo

Chaozhao Liang

Zisong He

Lijun Chen

Weiyang He

Li Yang

Hui Chen

Xiaoping Zhang

Shaogang Wang

Weiqing Han

Yuhua Huang

Ziling Liu

Bin Hu

Benkang Shi

Danfeng Xu

Xiaoming Cao

Liao Hong

Xin Yao

Hailong Hu

Liping Xie

Shaoxing Zhu

Haiying Dong

This is a phase 2, multicenter, single arm, open-lable study of ICP-192. The purpose of this study is to evaluate efficacy of ICP-192 in subjects with surgically unresectable or metastatic bladder urothelial cancer.

An Efficacy and Safety Study of ICP-192 in Subjects With Bladder Urothelial Cancer

A Phase 2, Multicenter, Single Arm, Open-lable Study of ICP-192 in Subjects With Surgically Unresectable or Metastatic Bladder Urothelial Cancer With FGFR Genetic Aberrations.

Beijing InnoCare Pharma Tech Co., Ltd.

Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

Pharmaceutical Solutions

All Drugs and Chemicals

Micronutrients

Amino Acids

Glycine

Silicon

Patients randomized to HoLERBT group will have their tumor resected using the Megapulse 70w (Richard Wolf).

Patients randomized to control arm will undergo a monopolar transurethral resection of bladder tumor.

Patients randomized to Monopolar TURBT will be operated using a 26F continuous-flow resectoscope sheaths and a single-pole working element to exclusive use of the resection. The power will be set to cut in 80w and 60w. The technique that will be performed will be the classic endoscopic resection from the top of the tumor until reaching the base, taking a sample from the base of the lesion (muscle layer). Fragments will be removed through an Ellik evacuator, and the solution used will be 3% glycine. After the procedure, the patient will will be catheterized with a silicon catheter number 22F with three ways and continuous irrigation.

After 30-60 days of the first procedure, all patients diagnosed with a lamina propria invasion in the uro-pathology analysis (T1) will be submitted to a new monopolar TURBT.

Monopolar Transurethral resection of bladder tumor

It will be used a 24-26F continuous-flow resectoscope sheath with a specific working element to use with a 600µm fiber to Laser Holmium.

Patients will be operated with the Megapulse 70w (Richard Wolf) and laser will be set to deliver the energy of 0,5J and 30-40Hz frequency, 15-20W of final energy. The solution used will be 0,9% saline solution. The resection will start from the base of the lesion, reaching the muscle layer to obtain a sample and resection of the whole tumor, without fragmentation. After this, the morcellation will be performed in the apex of tumor sparing the base with a long nephroscope, and the patient will will be catheterized with a silicon catheter number 22F with three ways and continuous irrigation. The morcellated product will be sent to the pathology lab for detailed analysis.

Holmium Laser resection of bladder tumor (HoLEBT)

Alexandre Iscaife, MD, PhD

William Nahas, MD, PhD

Bladder urothelial cancer is the second most common urologic tumor and represents a worldwide public health problem. Most cases are diagnosed as non-muscle invasive tumors, and can be treated with transurethral resection of bladder tumor (TURBT). However, the electrical energy-based TURBT fragments the tumor, burning it to its own muscular layer leading to artifacts that may spoil the histopathological analysis, resulting in understaging after the first TURBT ranging from 30-64%, depending on the presence of detrusor muscle. Modern laser technologies have been emerging as an alternative to classical TURB using en bloc tumor resection technique (ERBT). Therefore, the laser is applied on tumor's pedicle to resect the whole and intact tumor without fragmentation or fulguration as occurs in TURBT. The purpose of using laser if to improve the resection quality, decrease intra and perioperative complications, avoid re-TURBT and reduce recurrence rates at the resection site and in distant sites. Thus, the purpose of this study is to evaluate Laser Holmium use for large tumors resection (\>3cm), reducing complications, costs, and the need for new approaches, and improving the muscle layers samples.

This is a single-institution, randomized, single-blinded, prospective, controlled study, with 2 groups - 50 patients in Holmium Laser En-bloc Resection of Bladder Tumors (HoLERBT) arm and 50 patients in TURBT arm. All the patients will undergo a new procedure between 30-60 days after the first one (monopolar re-TURBT). The laser group will be operated by an experienced surgeon with more than 50 cases of prostate resection. The monopolar TURBT group will be operated by institutions´s surgeons assistants, urologists with more than 2 years of experience in the area and more than 50 surgeries performed. Pathological samples will be analyzed in the FMUSP Urology Laboratory by a pathologist with huge experience in analysis of bladder tumors.

Safety Analysis and Oncological Outcomes in HoLERT vs TURBT

Safety Analysis and Oncological Outcomes in Endoscopic Bladder Tumor Resection With Laser Holmium Compared With Transurethral Resection: a Prospective and Randomized Study

Evaluate the presence of muscle layer in the samples of tumor resection

Evaluate intra and peri-operative complications (according to Clavien-Dindo scale) between the two groups

Clinical recurrence-free survival at 3, 6, 9, 12, 15, 18 and 24 months follow-up (US, CT-scan, MRI, cystoscopy, TURBT)

Clinical progression-free survival at 3, 6, 9, 12, 15, 18 and 24 months follow-up (US, CT-scan, MRI, TURBT)

Overall and cancer-specific survival at 13, 6, 9, 12, 15, 18 and 24 months follow-up

Instituto do Cancer do Estado de São Paulo

Md, PhD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
An Efficacy and Safety Study of ICP-192 in Subjects With Bladder Urothelial Cancer	NCT04492293	Bladder Urothel...	ICP-192	18 Years -	Beijing InnoCare Pharma Tech Co., Ltd.
Safety Analysis and Oncological Outcomes in HoLERT vs TURBT	NCT05833997	Bladder Urothel... Bladder Cancer	Monopolar Trans... Holmium Laser r...	18 Years - 80 Years	Instituto do Cancer do Estado de São Paulo

Spots Global Cancer Trial Database for bladder urothelial cancer