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Filter by:Study design This study is a Phase III, randomized, open-label, multi-center, global study to determine the efficacy of a single immediate intravesical chemotherapy instillation (SI) in the prophylaxis of intravesical recurrence after diagnostic uretero-renoscopy (URS) of patients 18 years of age or older with the fist diagnosis of UTUC. This study will randomize 394 patients globally Patients will be randomized in a 1:1 ratio to the interventional arm or to observation. Study period This study will include a screening period, a treatment and disease assessment period, safety follow-up visits and a 5-year survival follow-up period to begin immediately after the treatment. Screening period: The period up to 28 days prior to intervention during which the screening procedures occur. Treatment and disease assessment period: The period starting the day of diagnostic URS (Day 0) during which patients receive their assigned treatment (Day 0 to day 1) and disease assessments are performed. All patients must follow the disease assessment schedule, which includes disease assessments at screening and every 3 months (±1 week) from the date of intervention until 24 months from the date of randomization, and then every 6 months for up to 5 years. The treatment and disease assessment period will end at the time of intravesical recurrence, death, or MINERVA-CTU decision to terminate the trial early. Safety follow-up visits: Every patient in this study will be assessed for the occurrence of adverse events (AEs) and serious adverse events from the time of signed informed consent until 90 days after the administration of SI. All patients who receive SI will have safety visits 4, 8, and 12 weeks following administration of SI. Safety assessments include targeted physical examination, complications according to Dindo-Clavien classification and patient-reported outcomes (PRO) assessments. Survival follow-up period: Patients will be followed up at in-clinic site visits, by telephone contact, or by contact with the patient's current physician for up to 5 years from the date of randomized into this study. Objectives Primary objective Efficacy of a SI in the prophylaxis of intravesical recurrence after diagnostic URS for UTUC Secondary objectives - Time to intravesical recurrence - 5-years intravesical recurrence rates - Incidence of high-grade BCa recurrence - Incidence and gravity of adverse events (AEs) due to the SI - To collect and store blood, urine and tissue samples according to each country's local and ethical procedures for identifying candidate markers that may correlate with likelihood of clinical benefit (optional) - To collect and store DNA according to each country's local and ethical procedures for future exploratory research into somatic mutations and genes/genetic variations that may influence oncologic outcomes, to study treatments and susceptibility to disease (optional) - To assess disease-related symptoms and HRQoL in patients with UTUC treated with SI compared those undergoing observation - To assess patient-reported treatment tolerability directly using specific PRO-CTCAE symptoms Target study population The study population includes patients 18 years of age or older with a primary diagnosis of UTUC, scheduled for diagnostic URS Duration of treatment Patients randomized to the interventional arm will receive a SI within 24h after diagnostic URS. In case of multiple diagnostic URS during the follow-up (including 2nd look for incomplete ablation, non-diagnostic first URS or UTUC recurrence) patients randomized to the interventional arm will receive a SI after each diagnostic URS for 2 years after the day of first diagnostic URS. Follow-up of subjects post discontinuation of study treatment Patients who have discontinued study treatment due to toxicity, symptomatic deterioration, intravesical recurrence or investigator's decision will be followed up for survival until 5 years from the date of diagnostic URS. Survival All randomized patients, regardless of disease status, will be followed up for survival until 5 years from the date of diagnostic URS. Investigational product, dosage, and mode of administration Patients randomized to the interventional arm will receive a SI. The chemotherapy will be at investigator's discretion and institutional availability. The selected chemotherapy must be approved by the MINERVA-CTU in discussion with the local investigator. Statistical methods This study will randomize 394 patients globally. Patients will be randomized 1:1 to SI or observation. Randomization will be stratified by the following factors: 1. Center 2. EAU UTUC risk stratification
The goal of this prospective clinical trial is to identify a predictive biomarker in patients with advanced HCC (stage B and C) using a combinatorial approach of the liquid biopsy. The main questions it aims to answer are: - Is multi-omic liquid biopsy approach able to identify a strong predictive biomarker of immunotherapy efficiency? - Is there a correlation between tissue biopsy (PD-L1 tissue level of expression) and liquid biopsy (detection of CTC expressing PD-L1) in HCC patients? Participants blood will be collected at several time points.
This is a Phase Ib/II, open-label, single arm trial to evaluate the efficacy and safety of AK104 in combination with axitinib as a first-line treatment for advanced/metastatic special pathological subtypes of renal cell carcinoma (ssRCC). Subjects will receive AK104 plus axitinib until disease progression, development of unacceptable toxic effects, death, a decision by the physician or patient to withdraw from the trial. The primary endpoint is ORR and PFS per RECIST v1.1 and imRECIST as assessed by investigators.
This is a phase II prospective study to evaluate the safety and efficacy of Tislelizumab monotherapy or combined with lenvatinib as neoadjuvant therapy for resectable hepatocellular carcinoma.
Cervical lymph node metastasis is the most important prognostic factor of oral squamous cell carcinoma (OSCC). Therapeutic neck dissection (I-V region) has always been regarded as the standard scheme of neck surgery for patients with cN+ OSCC and however, it has brought obvious side effects, which seriously affects the postoperative quality of life of patients. In addition, excessive neck lymph node dissection will also affect the local immune function of patients to some extent and reduce the body's response to immunotherapy. Lymph node metastasis of primary oral squamous cell carcinoma follows certain rules. Most of the metastatic areas are I-II, and low-level metastasis is very rare. Therefore, more than 90% of patients with cN+ oral squamous cell carcinoma who have undergone Therapeutic neck dissection may have suffered from "excessive dissection of area of IV and V". Both the long-term clinical experience of surgeons and a large number of recent retrospective studies show that elective neck dissection (I-III region) is safe enough for patients with oral squamous cell carcinoma of cN1 and part of cN2.There is clearly a need therefore for a large randomized trial that will resolve the issue either way once and for all.
This study aims to investigate the efficacy and safety of neoadjuvant Toripalimab combined with Nimotuzumab in primary limited stage oral squamous cell carcinoma prior to radical therapy.
This study investigates the safety and efficacy of sodium pentaborate pentahydrate in patients with advanced renal cell carcinoma.
The incidence and mortality of esophageal squamous cell carcinoma are at the forefront in China.Most part of patients are elderly. Concurrent chemoradiotherapy is the standard treatment for unresectable locally advanced esophageal squamous cell carcinoma. Most elderly patients cannot tolerate concurrent chemotherapy because of complications and other reasons. Immunotherapy has definite efficacy and low toxicity in advanced esophageal squamous cell carcinoma, and the results combined with radiotherapy have also been preliminarily reported. Therefore, it is necessary to further explore the efficacy and safety of radiotherapy combined with immunotherapy in elderly patients with esophageal squamous cell carcinoma.
Toxic and side effects during and after chemoradiotherapy for nasopharyngeal carcinoma seriously affect patients' treatment compliance and long-term quality of life. Active and effective prediction, prevention and management of toxic and side effects is an important element to improve the prognosis of patients. Leucogen has the ability to promote the growth and maturation of granulocytes in the bone marrow and the proliferation of leukocytes, and is widely used in radiation therapy and chemotherapy-induced leukopenia in malignant carcinomas. In addition, leucogen may have potential anticancer synergistic effects. Therefore, based on the application prospect of leucogen in preventing myelosuppression during chemotherapy for solid tumors, the study was designed to investigate the efficacy and safety of leucogen versus placebo on leukocyte and platelet whole-course management assisted by platinum plus low-dose long-term continuous intravenous infused 5-fluorouracil chemotherapy in the treatment of stage IV, recurrent or metastatic nasopharyngeal carcinoma.
The purpose of this study is to evaluate the effectiveness, safety, and actual treatment status of nivolumab administered as an adjuvant treatment for participants with muscle-invasive urothelial carcinoma (MIUC), including bladder, renal pelvis, and ureteral cancer, in a Japanese real-world clinical practice.